Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data, 56911-56925 [05-19510]
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Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices
Dated: September 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–19509 Filed 9–28–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N–0161] (formerly Docket
No. 03N–0161)
Medical Devices; Reprocessed SingleUse Devices; Termination of
Exemptions From Premarket
Notification; Requirement for
Submission of Validation Data
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is adding
noncompression heart stabilizers to the
list of critical reprocessed single-use
devices (SUDs) whose exemption from
premarket notification requirements has
been terminated and for which
validation data, as specified under the
Medical Device User Fee and
Modernization Act of 2002 (MDUFMA),
are necessary in a premarket notification
(510(k)). The agency is also adding
laparoscopic and endoscopic
electrosurgical accessories to the list of
reprocessed SUDs currently subject to
premarket notification requirements that
will now require submission of
supplemental validation data. FDA is
requiring submission of these data to
ensure that reprocessed single-use
noncompression heart stabilizers and
laparoscopic and endoscopic
electrosurgical accessories are
substantially equivalent to predicate
devices, in accordance with MDUFMA.
DATES: These actions are effective
September 29, 2005. Manufacturers of
reprocessed single-use noncompression
heart stabilizers must submit 510(k)s for
these devices by December 29, 2006, or
their devices may no longer be legally
marketed. Manufacturers of reprocessed
single-use laparoscopic and endoscopic
electrosurgical accessories who already
have 510(k) clearance for these devices
must submit supplemental validation
data for the devices by June 29, 2006, or
their devices may no longer be legally
marketed.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
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www.fda.gov/dockets/ecomments.
Comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Barbara A. Zimmerman, Center for
Devices and Radiological Health (HFZ–
410), Food and Drug Administration,
9200 Corporate Blvd., Rockville, MD
20850, 301–443–8320, ext. 158.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, MDUFMA
(Public Law 107–250), amended the
Federal Food, Drug, and Cosmetic Act
(the act) by adding section 510(o) (21
U.S.C. 360(o)), which provided new
regulatory requirements for reprocessed
SUDs. According to this new provision,
in order to ensure that reprocessed
SUDs are substantially equivalent to
predicate devices, 510(k)s for certain
reprocessed SUDs identified by FDA
must include validation data. These
required validation data include
cleaning and sterilization data, and
functional performance data
demonstrating that each SUD will
remain substantially equivalent to its
predicate device after the maximum
number of times the device is
reprocessed as intended by the person
submitting the premarket notification.
Before enactment of the new law, a
manufacturer of a reprocessed SUD was
required to obtain premarket approval
or premarket clearance for the device,
unless the device was exempt from
premarket submission requirements.
Under MDUFMA, some previously
exempt reprocessed SUDs are no longer
exempt from premarket notification
requirements. Manufacturers of these
identified devices were required to
submit 510(k)s that included validation
data specified by FDA. Reprocessors of
certain SUDs already subject to cleared
510(k)s were also required to submit the
validation data specified by the agency.
The reprocessed SUDs subject to these
new requirements were listed in the
Federal Register as required by
MDUFMA. In accordance with section
510(o) of the act, FDA shall revise the
lists as appropriate. This notice adds
two types of reprocessed SUDs to the
lists of devices subject to MDUFMA’s
data submission requirements.
Noncompression heart stabilizers are
being added to the list of previously
exempt reprocessed SUDs that now
require the submission of 510(k)s
containing validation data.
Laparoscopic and endoscopic
electrosurgical accessories are being
added to the list of reprocessed SUDs,
already subject to premarket notification
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56911
requirements, for which supplemental
validation data are required.
A. Definitions
Under section 302(b) of MDUFMA, a
reprocessed SUD is defined as an
‘‘original device that has previously
been used on a patient and has been
subjected to additional processing and
manufacturing for the purpose of an
additional single use on a patient. The
subsequent processing and manufacture
of a reprocessed single-use device shall
result in a device that is reprocessed
within the meaning of this definition.’’
Reprocessed SUDs are divided into
three groups: (1) critical, (2)
semicritical, and (3) noncritical. The
first two categories reflect definitions set
forth in MDUFMA, and all three reflect
a classification scheme recognized in
the industry.1 These categories of
devices are defined as follows:
(1) A critical reprocessed SUD is
intended to contact normally sterile
tissue or body spaces during use.
(2) A semicritical reprocessed SUD is
intended to contact intact mucous
membranes and not penetrate normally
sterile areas of the body.
(3) A noncritical reprocessed SUD is
intended to make topical contact and
not penetrate intact skin.
B. Critical and Semicritical Reprocessed
SUDs Previously Exempt From
Premarket Notification
MDUFMA required FDA to review the
critical and semicritical reprocessed
SUDs that were previously exempt from
premarket notification requirements and
determine which of these devices
required premarket notification to
ensure their substantial equivalence to
predicate devices. By April 26, 2003,
FDA was required to identify in a
Federal Register notice those critical
reprocessed SUDs whose exemption
from premarket notification would be
terminated and for which FDA
determined that validation data, as
specified under MDUFMA, was
necessary in a 510(k). According to the
law, manufacturers of the devices whose
exemptions from premarket notification
were terminated were required to
submit 510(k)s that included validation
data regarding cleaning, sterilization,
and functional performance, in addition
to all the other required elements of a
510(k) identified in § 807.87 (21 CFR
807.87), within 15 months of
1Spaulding, E.H., ‘‘The Role of Chemical
Disinfection in the Prevention of Nonsocomial
Infections,’’ P.S. Brachman and T.C. Eickof (ed),
Proceedings of International Conference on
Nonsocomial Infections, 1970, American Hospital
Association, Chicago, 254-274, 1971.
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publication of the notice or no longer
market their devices.
In accordance with section 510(o) of
the act, FDA must revise the list of
devices subject to this requirement as
appropriate. On June 26, 2003 (68 FR
38071), FDA recategorized nine device
types from semicritical to critical, and
added nonelectric gastroenterologyurology biopsy forceps to the list of
critical devices whose exemption from
premarket notification requirements was
being terminated.
By April 26, 2004, FDA was required
to identify in a Federal Register notice
those semicritical reprocessed SUDs
whose exemption from premarket
notification would be terminated and
for which FDA determined that
validation data, as specified under
MDUFMA, was necessary in a 510(k).
As discussed above, manufacturers of
the devices whose exemptions from
premarket notification were terminated
were required to submit 510(k)s that
included validation data regarding
cleaning, sterilization, and functional
performance, in addition to all the other
required elements of a 510(k) identified
in § 807.87, within 15 months of
publication of the notice or no longer
market their devices. In accordance with
section 510(o) of the act, FDA must
revise the list of devices subject to this
requirement as appropriate.
C. Reprocessed SUDs Already Subject to
Premarket Notification Requirements
MDUFMA also required FDA to
review the types of reprocessed SUDs
already subject to premarket notification
requirements and to identify which of
these devices required the submission of
validation data to ensure their
substantial equivalence to predicate
devices. FDA published a list of these
devices in the Federal Register on April
30, 2003 (68 FR 23139). As described
above, FDA must revise the list of
devices subject to this requirement as
appropriate.
For devices identified on this list that
had already been cleared through the
510(k) process, manufacturers were
required to submit validation data
regarding cleaning, sterilization, and
functional performance within 9 months
of publication of the list or no longer
market their devices.
For devices on this list that were not
yet cleared through the 510(k) process,
manufacturers were required to submit
510(k)s including validation data
regarding cleaning, sterilization, and
functional performance, in addition to
all the other required elements
identified in 21 CFR 807.87, in order to
market these devices.
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II. FDA’s Implementation of New
Section 510(o) of the Act
In the Federal Register of April 30,
2003 (68 FR 23139), FDA described the
methodology and criteria used to
identify the reprocessed SUDs that were
included in the lists required by
MDUFMA. First, FDA described how it
identified the types of SUDs currently
being reprocessed and how the
Spaulding definitions (see footnote 1)
were used to categorize these devices as
critical, semicritical, or noncritical. (See
Attachment 1.) Next, the agency
described its use of the Risk
Prioritization Scheme (RPS)2 that was
used to evaluate the potential risk (high,
moderate, or low) associated with an
SUD based on the following factors: (1)
Risk of infection and (2) risk of
inadequate performance following
reprocessing. FDA identified its final
criterion as those reprocessed SUDs
intended to come in contact with tissue
at high risk of being infected with the
causative agents of Creutzfeldt-Jakob
Disease (CJD). (These are generally
devices intended for use in
neurosurgery and ophthalmology.)
Using this methodology and these
criteria, the devices included on List I
(Critical and Semicritical Reprocessed
SUDs Previously Exempt from
Premarket Notification Requirements
that Now Require 510(k)s with
Validation Data) of the April 30, 2003,
June 26, 2003, and April 13, 2004,
Federal Register notices are those
critical and semicritical reprocessed
SUDs that were either high risk
according to the RPS or intended to
come in contact with tissue at high risk
of being infected with CJD. The devices
included on List II (Reprocessed SUDs
Subject to Premarket Notification
Requirements that Now Require the
Submission of Validation Data) of the
April 30, 2003, Federal Register notice
are those reprocessed SUDs already
subject to premarket notification
requirements that were either high risk
according to the RPS or intended to
come in contact with tissue at high risk
of being infected with CJD.
III. Revisions to Attachment 1, List I,
and List II
A. Revisions to Attachment 1 (List of
SUDs Known To Be Reprocessed or
Considered for Reprocessing)
FDA has evaluated the comments
received regarding section 510(o) of the
act. In doing so, the agency has
2This scheme is described in the February 2000
draft guidance document entitled, ‘‘Reprocessing
and Reuse of Single-Use Devices: Review
Prioritization Scheme.’’ https://www.fda.gov/cdrh/
reuse/1156.html.
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determined that all noncompression
heart stabilizers and endoscopic and
laparoscopic electrosurgical accessories
should be considered high risk devices
when reprocessed.
Noncompression heart stabilizers are
intended to move, lift, and position the
heart while maintaining hemodynamic
stability during cardiovascular surgery.
The agency has determined that
noncompression heart stabilizers are
high risk devices when reprocessed
because they include features, such as
narrow tubing, interlocking parts, and
small crevices that could impede
cleaning and sterilization and because
these devices contain materials,
coatings, or components that may be
damaged or altered by reprocessing.
Therefore, these devices have the
potential for a high risk of infection
and/or inadequate performance when
reprocessed. This includes
noncompression heart stabilizers
(device 21 in Attachment 1) classified
under § 870.4500 (21 CFR 870.4500). In
determining that noncompression heart
stabilizers are high risk devices when
reprocessed, a new product code has
been created to identify these devices
within regulation § 870.4500. The new
product code is NQG. This new product
code has been added to device 21 in
Attachment 1 of this document.
Endoscopic and laparoscopic
electrosurgical accessories are surgical
instruments used during minimally
invasive surgery, including vein
harvesting. The agency has determined
that these devices should be considered
high risk devices when reprocessed
because they include features, such as
narrow lumens, that could impede
thorough cleaning and sterilization and
because these devices contain materials,
coatings, or components that may be
damaged or altered by reprocessing.
Therefore, these devices have the
potential for a high risk of infection or
inadequate performance when
reprocessed. This includes endoscopic
and laparoscopic electrosurgical
accessories (device 162 in Attachment
1) classified under § 878.4400 (21 CFR
878.4400). In determining that
endoscopic and laparoscopic
electrosurgical accessories are
potentially high risk devices when
reprocessed, a new product code has
been created to identify these devices
within regulation § 878.4400. The new
product code is NUJ. This new product
code has been added to device 162 in
Attachment 1.
These changes are reflected in a
revised version of Attachment 1
included in this Federal Register notice.
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B. Revisions to List I (Critical and
Semicritical Reprocessed Single-Use
Devices Previously Exempt from
Premarket Notification Requirements
that Now Require 510(k)s with
Validation Data)
Using the RPS, FDA has recategorized
noncompression heart stabilizers from
moderate risk to high risk when
reprocessed, and the agency has
therefore added noncompression heart
stabilizers to List I. Manufacturers of
noncompression heart stabilizers will be
required to submit 510(k)s with
validation data by December 29, 2006,
which is 15 months following this
revision of the list.
To help reprocessors be able to easily
identify those critical and semicritical
reprocessed SUDs that have been
categorized into List I in this notice and
previous Federal Register notices, FDA
is re-issuing a complete listing of these
devices. Therefore, List 1 now identifies
all critical and semicritical reprocessed
SUDs previously exempt from
premarket notification requirements that
now require 510(k)s with validation
data.
C. Revisions to List II (Reprocessed
Single-Use Devices Subject to Premarket
Notification Requirements that Now
Require the Submission of Validation
Data)
Using the RPS, FDA has recategorized
endoscopic and laparoscopic
electrosurgical accessories under
regulation § 878.4400 from moderate
risk to high risk when reprocessed.
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Therefore, endoscopic and laparoscopic
electrosurgical accessories have been
added to List II. Under MDUFMA,
manufacturers of these devices who
have already obtained clearance through
the 510(k) process must submit
validation data regarding cleaning,
sterilization, and functional
performance by June 29, 2006, which is
9 months following this revision of the
list. Upon publication of this notice,
manufacturers who have not yet
obtained clearance through the 510(k)
process must submit 510(k)s including
validation data regarding cleaning,
sterilization, and functional
performance, in addition to all the other
required elements of a 510(k) identified
in 21 CFR 807.87, in order to market
these devices.
LIST I.—CRITICAL AND SEMICRITICAL REPROCESSED SINGLE-USE DEVICES PREVIOUSLY EXEMPT FROM PREMARKET NOTIFICATION REQUIREMENTS THAT NOW REQUIRE 510(K)S WITH VALIDATION DATA [MANUFACTURERS OF NONCOMPRESSION HEART STABILIZERS WILL NEED TO SUBMIT 510(K)S WITH VALIDATION DATA BY 15 MONTHS FOLLOWING THE PUBLICATION OF THIS REVISED LIST.]
21 CFR No.
Product code for nonreprocessed
device
Classification name
Product code for
reprocessed
device
Product code name for
reprocessed device
868.6810
Tracheobronchial suction catheter
BSY
NQV
Tracheobronchial suction catheter
870.4500
Cardiovascular surgical instruments
MWS
NQG
Noncompression heart stabilizer
872.3240
Dental bur
Diamond coated
NME
Dental diamond coated bur
872.4535
Dental diamond instrument
DZP
NLD
Dental diamond instrument
872.4730
Dental injection needle
DZM
NMW
Dental needle
872.5410
Orthodontic appliance and accessories
EJF
NQS
Orthodontic metal bracket
874.4140
Ear, nose, and throat bur
Microdebrider
NLY
ENT high speed microdebrider
874.4140
Ear, nose, and throat bur
Diamond coated
NLZ
ENT diamond coated bur
874.4420
Ear, nose, throat manual surgical ..
KAB, KBG, KCI
NLB
Laryngeal, sinus, tracheal trocar
876.1075
Gastroenterology-urology biopsy instrument
FCL
NON
Nonelectric biopsy forceps
876.4680
Ureteral stone dislodger
FGO, FFL
NQT, NQU
Flexible and basket stone
dislodger
878.4200
Introduction/drainage catheter and accessories
GCB
NMT
Catheter needle
878.4800
Manual surgical instrument
MJG
NNA
Percutaneous biopsy device
878.4800
Manual surgical instrument
FHR
NMU
Gastro-Urology needle
878.4800
Manual surgical instrument for ... ....
DWO
NLK
Cardiovascular biopsy needle
878.4800
Manual surgical instrument for...
GAA
NNC
Aspiration and injection needle
882.4190
Forming/cutting clip instrument
HBS
NMN
Forming/cutting clip instrument
884.1730
Laparoscopic insufflator, ..
HIF
NMI
Laparoscopic insufflator and accessories
884.4530
OB/GYN specialized manual instrument
HFB
NMG
Gynecological biopsy forceps
886.4350
Manual ophthalmic surgical instrument
HNN
NLA
Ophthalmic knife
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LIST II.—REPROCESSED SINGLE-USE DEVICES SUBJECT TO PREMARKET NOTIFICATION REQUIREMENTS THAT NOW REQUIRE THE SUBMISSION OF VALIDATION DATA1 [MANUFACTURERS OF ENDOSCOPIC AND LAPAROSCOPIC
ELECTROSURGICAL ACCESSORIES WHO ALREADY HAVE 510(K) CLEARANCE FOR THESE DEVICES MUST SUBMIT VALIDATION DATA BY JUNE 29, 2006. ANY NEW 510(K) FOR THIS DEVICE TYPE WILL REQUIRE VALIDATION DATA UPON PUBLICATION OF THIS DOCUMENT.]
21 CFR No.
Product code for
nonreprocessed
device
Classification name
Product code for
reprocessed
device
Product code name for
reprocessed device
Unclassified
Oocyte aspiration needles
MHK
NMO
Oocyte aspiration needles
Unclassified
Percutaneous transluminal angioplasty catheter
LIT
NMM
Transluminal peripheral
angioplasty catheter
Unclassified
Ultrasonic surgical instrument
LFL
NLQ
Ultrasonic scalpel
868.5150
Anesthesia conduction needle
BSP
NNH
Anesthetic conduction needle
(with/without introducer)
868.5150
Anesthesia conduction needle
MIA
NMR
Short term spinal needle
868.5730
Tracheal tube
BTR
NMA
Tracheal tube (with/without connector)
868.5905
Noncontinuous ventilator (IPPB)
BZD
NMC
Noncontinuous ventilator (respirator) mask
870.1200
Diagnostic intravascular catheter
DQO
NLI
Angiography catheter
870.1220
Electrode Recording Catheter
DRF
NLH
Electrode recording catheter
870.1220
Electrode Recording Catheter
MTD
NLG
Intracardiac mapping catheter
870.1230
Fiberoptic oximeter catheter
DQE
NMB
Fiberoptic oximeter catheter
870.1280
Steerable Catheter
DRA
NKS
Steerable Catheter
870.1290
Steerable catheter control system
DXX
NKR
Steerable catheter control system
870.1330
Catheter guide wire
DQX
NKQ
Catheter guide wire
870.1390
Trocar
DRC
NMK
Cardiovascular trocar
870.1650
Angiographic injector and syringe
DXT
NKT
Angiographic injector and syringe
870.1670
Syringe actuator for injector
DQF
NKW
Injector for actuator syringe
870.2700
Oximeter
MUD
NMD
Tissue saturation oximeter
870.2700
Oximeter
DQA
NLF
Oximeter
870.3535
Intra-aortic balloon and control system
DSP
NKO
Intra-aortic balloon and control
system
870.4450
Vascular clamp
DXC
NMF
Vascular clamp
870.4885
External vein stripper
DWQ
NLJ
External vein stripper
872.5470
Orthodontic Plastic Bracket
DYW
NLC
Orthodontic Plastic Bracket
874.4680
Bronchoscope (flexible or rigid) and accessories
BWH
NLE
Bronchoscope (nonrigid) biopsy
forceps
876.1075
Gastro-Urology biopsy instrument
FCG
NMX
G-U biopsy needle and needle
set
876.1075
Gastroenterology-urology biopsy instrument
KNW
NLS
Biopsy instrument
876.1500
Endoscope and accessories
FBK, FHP
NMY
Endoscopic needle
876.1500
Endoscope and accessories
MPA
NKZ
Endoilluminator
876.1500
Endoscope and accessories
GCJ
NLM
General and plastic surgery
laparoscope
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LIST II.—REPROCESSED SINGLE-USE DEVICES SUBJECT TO PREMARKET NOTIFICATION REQUIREMENTS THAT NOW REQUIRE THE SUBMISSION OF VALIDATION DATA1 [MANUFACTURERS OF ENDOSCOPIC AND LAPAROSCOPIC
ELECTROSURGICAL ACCESSORIES WHO ALREADY HAVE 510(K) CLEARANCE FOR THESE DEVICES MUST SUBMIT VALIDATION DATA BY JUNE 29, 2006. ANY NEW 510(K) FOR THIS DEVICE TYPE WILL REQUIRE VALIDATION DATA UPON PUBLICATION OF THIS DOCUMENT.]—Continued
21 CFR No.
Product code for
nonreprocessed
device
Classification name
Product code for
reprocessed
device
Product code name for
reprocessed device
876.1500
Endoscope and accessories
FHO
NLX
Spring-loaded
pneumoperitoneum needle
876.4300
Endoscopic electrosurgical unit and accessories
FAS
NLW
Active Urological electrosurgical
electrode
876.4300
Endoscopic electrosurgical unit and accessories
FEH
NLV
Flexible suction coagulator electrode
876.4300
Endoscopic electrosurgical unit and accessories
KGE
NLU
Electric biopsy forceps
876.4300
Endoscopic electrosurgical unit and accessories
FDI
NLT
Flexible snare
876.4300
Endoscopic electrosurgical unit and accessories
KNS
NLR
Endoscopic (with or without accessories) Electrosurgical unit
876.5010
Biliary catheter and accessories
FGE
NML
Biliary catheter
876.5540
Blood access device and accessories
LBW
NNF
Single needle dialysis set (coaxial flow)
876.5540
Blood access device and accessories
FIE
NNE
Fistula needle
876.5820
Hemodialysis systems and accessories
FIF
NNG
Single needle dialysis set with
uni-directional pump
878.4300
Implantable clip
FZP
NMJ
Implantable clip
878.4400
Electrosurgical Cutting and Coagulation Device and Accessories
GEI
NUJ
Endoscopic and laparoscopic
electrosurgical accessories
878.4750
Implantable staple
GDW
NLL
Implantable staple
880.5570
Hypodermic single lumen needle
FMI
NKK
Hypodermic single lumen needle
880.5860
Piston Syringe
FMF
NKN
Piston Syringe
882.4300
Manual cranial drills, burrs, trephines and
accessories
HBG
NLO
(Manual) drills, burrs, trephines
and accessories
882.4305
Powered compound cranial drills, burrs,
trephines .
HBF
NLP
(Powered, compound) drills,
burrs, trephines and accessories
882.4310
Powered simple cranial drills, burrs,
trephines .
HBE
NLN
(Simple, powered) drills, burrs,
trephines and accessories
884.1720
Gynecologic laparoscope and accessories
HET
NMH
Gynecologic laparoscope (and
accessories)
884.6100
Assisted reproduction needle
MQE
NNB
Assisted reproduction needle
886.4370
Keratome
HMY, HNO
NKY
Keratome blade
886.4670
Phacofragmentation system
HQC
NKX
Phacoemulsification needle
892.5730
Radionuclide brachytherapy source
IWF
NMP
Isotope needle
1Hemodialyzers
have been excluded from this list because the reuse of hemodialyzers is addressed in ‘‘Draft Guidance for Hemodialyzer
Reuse Labeling’’ October 6, 1995. An archived copy may be obtained from CDRH’s Division of Small Manufacturers, International, and Consumer Assistance, please contact dsmica@cdrh.fda.gov.
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IV. Stakeholder Input
In the Federal Register of February 4,
2003 (68 FR 5643), FDA invited
interested persons to provide
information and share views on the
implementation of MDUFMA. Since
that time, the agency has received
comments on various MDUFMA
provisions, including several on its
implementation of section 510(o) of the
act. As discussed above, one comment
recommended that heart stabilizers
should be considered high risk because
of the risk of cross contamination and
deterioration of the mechanical
properties of the device. FDA agrees that
noncompression heart stabilizers, a
subset of all heart stabilizers, should be
added to the list of critical reprocessed
SUDs previously exempt from
premarket notification requirements that
will now require 510(k)s with validation
data. Therefore, FDA has added
noncompression heart stabilizers to List
I.
Another comment recommended that
FDA recategorize endoscopic vessel
harvesting devices as high risk to be
consistent with the categorization of
other endoscopic accessories under 21
CFR 876.1500 (Endoscope and
accessories). FDA agrees that
endoscopic vessel harvesting devices
should be considered high risk and
subject to the submission of validation
data. As discussed previously, in
reviewing this comment, the agency also
determined that laparoscopic
electrosurgical accessories should be
similarly categorized. Therefore, FDA
has added laparoscopic and endoscopic
electrosurgical accessories to List II.
Other additional comments requested
that specific reprocessed SUDs be added
to either List I or II. Each of these
comments was carefully considered.
However, FDA does not believe, based
on the risk-based approach described in
the April 30, 2003, Federal Register
notice, that SUDs other than those
identified in this notice should be
added to the Lists at this time.
Another comment requested the FDA
to call for the immediate submission
and review of validation data regarding
cleaning, sterilization, and functional
performance for all reprocessed SUDs.
The comment further stated that this
request was based on the significant
number of reprocessed devices which
were withdrawn or were deemed to be
insufficiently supported by validation
data as of February 8, 2005.
Section 510(o) of the act required FDA
to identify those reprocessed SUDs for
which validation data must be
submitted in order to ensure that those
SUDs remain substantially equivalent to
predicate devices after reprocessing.
Because the agency has found that some
reprocessed SUDs do not require the
submission and review of validation
data in order to demonstrate substantial
equivalence, the agency identified the
types of devices requiring the
submission of validation data by
implementing a risk-based approach.
This risk-based approach, described in
the April 30, 2003, Federal Register
notice, identified a significant number
of reprocessed SUDs that can no longer
be legally marketed without agency
review and clearance of validation data.
The failure of some manufacturers to
submit this validation data and the
agency’s review of submitted data
resulted in a determination that a
significant number of reprocessed SUDs
could no longer be legally marketed.
However, the process also identified a
significant number of reprocessed SUDs
that could continue to be marketed
because: (1) they were found not to
require the submission of additional
validation data in order to ensure
substantial equivalence to legally
marketed predicate devices; or (2) after
a review of submitted validation data,
they were found to be substantially
equivalent to legally marketed predicate
devices. Therefore, FDA does not intend
to expand the list of reprocessed SUDs
subject to the submission and review of
validation data to all reprocessed SUDs
as requested in the comment. The
agency believes it has implemented
section 510(o) of the act by identifying
the types of devices that require the
submission of validation data and
determining which of those devices can
no longer be legally marketed.
V. Comments
You may submit written or electronic
comments on the designation of
reprocessed noncompression heart
stabilizers and laparoscopic and
endoscopic electrosurgical devices
requiring the submission of premarket
notifications with validation data to the
Division of Dockets Management (see
ADDRESSES). Submit electronic
comments to https://www.fda.gov/
dockets/ecomments. Submit two copies
of mailed comments, but individuals
may submit one copy. You should
identify your comments with the docket
number found in brackets in the
heading of this document. You may see
any comments FDA receives in the
Dockets Management Branch between 9
a.m. and 4 p.m., Monday through
Friday.
Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing
Medical
Specialty
Regulation
Number
Device Type
1
Cardio
Cardiopulmonary Bypass
Marker
Unclassified
2
Cardio
Percutaneous & Operative
Transluminal Coronary
Angioplasty Catheter
(PTCA)
Post-amendment
3
Cardio
Percutaneous Ablation
Electrode
4
Cardio
5
6
Class
Product
Code
RiskA
Critical/
Semicritical/Noncritical
Premarket
Exempt
MAB
1
C
N
III
LOX
3
C
N
Post-amendment
III
LPB
3
C
N
Peripheral Transluminal
Angioplasty (PTA) Catheter
870.1250
II
LIT
3
C
N
Cardio
Blood-Pressure Cuff
870.1120
II
DXQ
1
N
N
Cardio
Angiography Catheter
870.1200
II
DQO
3
C
N
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Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued
Medical
Specialty
Regulation
Number
Device Type
Class
Product
Code
RiskA
Critical/
Semicritical/Noncritical
Premarket
Exempt
7
Cardio
Electrode Recording Catheter
870.1220
II
DRF
3
C
N
8
Cardio
High-Density Array Catheter
870.1220
II
MTD
3
C
N
9
Cardio
Fiberoptic Oximeter Catheter
870.1230
II
DQE
3
C
N
10
Cardio
Steerable Catheter
870.1280
II
DRA
3
C
N
11
Cardio
Steerable Catheter Control
System
870.1290
II
DXX
3
C
N
12
Cardio
Guide Wire
870.1330
II
DQX
3
C
N
13
Cardio
Angiographic Needle
870.1390
II
DRC
3
C
N
14
Cardio
Trocar
870.1390
II
DRC
3
C
N
15
Cardio
Syringes
870.1650
II
DXT
3
C
N
16
Cardio
Injector Type Syringe Actuator
870.1670
II
DQF
3
C
N
17
Cardio
Oximeter
870.2700
II
DQA
3
N
N
18
Cardio
Tissue Saturation Oximeter
870.2700
II
MUD
3
C
N
19
Cardio
Intra-Aortic Balloon System
870.3535
III
DSP
3
C
N
20
Cardio
Vascular Clamp
870.4450
II
DXC
3
C
N
21
Cardio
Heart Stabilizer
870.4500
I
MWS
2
C
Y
22
Cardio
Noncompression Heart
Stabilizer
870.4500
I
MWS
3
C
Y
23
Cardio
External Vein Stripper
870.4885
II
DWQ
3
C
N
24
Cardio
Compressible Limb Sleeve
870.5800
II
JOW
1
N
N
25
Dental
Bur
872.3240
I
EJL
1
C
Y
26
Dental
Diamond Coated Bur
872.3240
I
EJL
3
C
Y
27
Dental
Diamond Instrument
872.4535
I
DZP
3
C
Y
28
Dental
AC-Powered Bone Saw
872.4120
II
DZH
2
C
N
29
Dental
Manual Bone Drill and
Wire Driver
872.4120
II
DZJ
2
C
N
30
Dental
Powered Bone Drill
872.4120
II
DZI
2
C
N
31
Dental
Intraoral Drill
872.4130
I
DZA
1
C
Y
32
Dental
Injection needle
872.4730
I
DZM
3
C
Y
33
Dental
Metal Orthodontic Bracket
872.5410
I
EJF
3
S
Y
34
Dental
Plastic Orthodontic Bracket
872.5470
II
DYW
3
S
N
35
ENT
Bur
874.4140
I
EQJ
1
C
Y
36
ENT
Diamond Coated Bur
874.4140
I
EQJ
3
C
Y
37
ENT
Microdebrider
874.4140
I
EQJ
3
C
Y
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Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued
Medical
Specialty
Regulation
Number
Device Type
Class
Product
Code
RiskA
Critical/
Semicritical/Noncritical
Premarket
Exempt
38
ENT
Microsurgical Argon Fiber
Optic Laser Cable, For
Uses Other Than
Otology, Including Laryngology & General Use
In Otolaryngology
874.4490
II
LMS
1
S
N
39
ENT
Microsurgical Argon Fiber
Optic Laser Cable, For
Use In Otology
874.4490
II
LXR
1
S
N
40
ENT
Microsurgical Carbon-Dioxide Fiber Optic Laser
Cable
874.4500
II
EWG
1
S
N
41
ENT
Bronchoscope Biopsy Forceps (Nonrigid)
874.4680
II
BWH
3
C
N
42
ENT
Bronchoscope Biopsy Forceps (Rigid)
874.4680
II
JEK
1
C
N
43
Gastro/ Urology
Biopsy Forceps Cover
876.1075
I
FFF
1
C
Y
44
Gastro/ Urology
Biopsy Instrument
876.1075
II
KNW
3
C
N
45
Gastro/ Urology
Biopsy Needle Set
876.1075
II
FCG
3
C
N
46
Gastro/ Urology
Biopsy Punch
876.1075
II
FCI
2
C
N
47
Gastro/ Urology
Mechanical Biopsy Instrument
876.1075
II
FCF
2
C
N
48
Gastro/ Urology
Nonelectric Biopsy Forceps
876.1075
I
FCL
3
C
Y
49
Gastro/ Urology
Cytology Brush For Endoscope
876.1500
II
FDX
2
S
N
50
Gastro/ Urology
Endoscope accessories
876.1500
II
KOG
2
S
N
51
Gastro/ Urology
Extraction Balloons/Baskets
876.1500
II
KOG
2
S
N
52
Gastro/Urology
Endoscopic needle
876.1500
II
FBK
3
C
N
53
Gastro/ Urology
Simple Pneumoperitoneum
Needle
876.1500
II
FHP
3
C
N
54
Gastro/ Urology
Spring Loaded
Pneumoperitoneum
Needle
876.1500
II
FHO
3
C
N
55
Gastro/ Urology
Active Electrosurgical
Electrode
876.4300
II
FAS
3
S
N
56
Gastro/ Urology
Biliary Sphincterotomes
876.5010,
876.1500
II
FGE
3
C
N
57
Gastro/ Urology
Electric Biopsy Forceps
876.4300
II
KGE
3
C
N
58
Gastro/ Urology
Electrosurgical Endoscopic
Unit (With Or Without
Accessories)
876.4300
II
KNS
3
S
N
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Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued
Medical
Specialty
Regulation
Number
Device Type
Class
Product
Code
RiskA
Critical/
Semicritical/Noncritical
Premarket
Exempt
59
Gastro/ Urology
Flexible Snare
876.4300
II
FDI
3
S
N
60
Gastro/ Urology
Flexible Suction Coagulator Electrode
876.4300
II
FEH
3
S
N
61
Gastro/ Urology
Flexible Stone Dislodger
876.4680
II
FGO
3
S
Y
62
Gastro/ Urology
Metal Stone Dislodger
876.4680
II
FFL
3
S
Y
63
Gastro/ Urology
Needle Holder
876.4730
I
FHQ
1
C
Y
64
Gastro/ Urology
Nonelectrical Snare
876.4730
I
FGX
1
S
Y
65
Gastro/ Urology
Urological Catheter
876.5130
II
KOD
2
S
N
66
Gastro/Urology
Single needle dialysis set
876.5540
II
LBW, FIE
3
C
N
67
Gastro/ Urology
Hemodialysis Blood Circuit
Accessories
876.5820
II
KOC
2
S
N
68
Gastro/Urology
Single needle dialysis set
876.5820
II
FIF
3
C
N
69
Gastro/Urology
Hemorrhoidal Ligator
876.4400
II
FHN
2
C
N
70
General
Hospital
Implanted, Programmable
Infusion Pump
Post-amendment
III
LKK
3
C
N
71
General
Hospital
Needle Destruction Device
Post-amendment
III
MTV
1
N
N
72
General
Hospital
Nonpowered Flotation
Therapy Mattress
880.5150
I
IKY
2
N
Y
73
General
Hospital
NonAC-Powered Patient
Lift
880.5510
I
FSA
2
N
Y
74
General
Hospital
Alternating Pressure Air
Flotation Mattress
880.5550
II
FNM
1
N
Y
75
General
Hospital
Temperature Regulated
Water Mattress
880.5560
I
FOH
2
N
Y
76
General
Hospital
Hypodermic Single Lumen
Needle
880.5570
II
FMI
3
C
N
77
General
Hospital
Piston Syringe
880.5860
II
FMF
3
C
N
78
General
Hospital
Mattress Cover (Medical
Purposes)
880.6190
I
FMW
2
N
Y
79
General
Hospital
Disposable Medical Scissors
880.6820
I
JOK
1
N
Y
80
General
Hospital
Irrigating Syringe
880.6960
I
KYZ, KYY
1
C
Y
81
Infection
Control
Surgical Gowns
878.4040
II
FYA
1
C
N
82
Lab
Blood Lancet
878.4800
I
FMK
1
C
Y
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Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued
Medical
Specialty
Regulation
Number
Device Type
Class
Product
Code
RiskA
Critical/
Semicritical/Noncritical
Premarket
Exempt
83
Neurology
Clip Forming/Cutting Instrument,
882.4190
I
HBS
3*
C
Y
84
Neurology
Drills, Burrs, Trephines
&Accessories (Manual)
882.4300
II
HBG
3*
C
N
85
Neurology
Drills, Burrs, Trephines
&Accessories (Compound, Powered)
882.4305
II
HBF
3*
C
N
86
Neurology
Drills, Burrs, Trephines
&Accessories (Simple,
Powered)
882.4310
II
HBE
3*
C
N
87
OB/GYN
Oocyte aspiration needle
III
MHK
3
C
N
88
OB/GYN
Laparoscope accessories
884.1720
I
HET
2
C
Y
89
OB/GYN
Laparoscope Accessories
884.1720
II
HET
3
C
N
90
OB/GYN
Laparoscopic Dissectors
884.1720
I
HET
2
C
Y
91
OB/GYN
Laparoscopic Graspers
884.1720
I
HET
2
C
Y
92
OB/GYN
Laparoscopic Scissors
884.1720
I
HET
2
C
Y
93
OB/GYN
Insufflator accessories
(tubing, Verres needle,
kits)
884.1730
II
HIF
3
C
Y
94
OB/GYN
Laparoscopic Insufflator
884.1730
II
HIF
2
N
N
95
OB/GYN
Endoscopic Electrocautery
and Accessories
884.4100
II
HIM
2
N
N
96
OB/GYN
Gynecologic
Electrocautery (and Accessories)
884.4120
II
HGI
2
N
N
97
OB/GYN
Endoscopic Bipolar Coagulator-Cutter (and Accessories)
884.4150
II
HIN
2
N
N
98
OB/GYN
Culdoscopic Coagulator
(and Accessories)
884.4160
II
HFI
2
N
N
99
OB/GYN
Endoscopic Unipolar Coagulator-Cutter (and Accessories)
884.4160
II
KNF
2
N
N
100
OB/GYN
Hysteroscopic Coagulator
(and Accessories)
884.4160
II
HFH
2
N
N
101
OB/GYN
Unipolar Laparoscopic Coagulator (and Accessories)
884.4160
II
HFG
2
N
N
102
OB/GYN
Episiotomy Scissors
884.4520
I
HDK
1
C
Y
103
OB/GYN
Umbilical Scissors
884.4520
I
HDJ
1
C
Y
104
OB/GYN
Biopsy Forceps
884.4530
I
HFB
3
C
Y
105
OB/GYN
Assisted reproduction needle
884.6100
II
MQE
3
C
N
106
Ophthalmic
Endoilluminator
876.1500
II
MPA
3*
C
N
107
Ophthalmic
Surgical Drapes
878.4370
II
KKX
2
C
N
108
Ophthalmic
Ophthalmic Knife
886.4350
I
HNN
3
C
Y
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Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued
Medical
Specialty
Regulation
Number
Device Type
Class
Product
Code
RiskA
Critical/
Semicritical/Noncritical
Premarket
Exempt
109
Ophthalmic
Keratome Blade
886.4370
I
HMY, HNO
3
C
N
110
Ophthalmic
Phacoemulsification Needle
886.4670
II
HQC
3
C
N
111
Ophthalmic
Phacoemulsification/
Phacofragmentation
Fluidic
886.4670
II
MUS
2
C
N
112
Ophthalmic
Phacofragmentation Unit
886.4670
II
HQC
1
N
N
113
Orthopedic
Saw Blades
878.4820
I
GFA, DWH,
GEY,
GET
1
C
Y
114
Orthopedic
Surgical Drills
878.4820
I
GEY, GET
1
C
Y
115
Orthopedic
Arthroscope accessories
888.1100
II
HRX
2
C
Y
116
Orthopedic
Bone Tap
888.4540
I
HWX
1
C
Y
117
Orthopedic
Burr
888.4540
I
HTT
1
C
Y
118
Orthopedic
Carpal Tunnel Blade
888.4540
I
LXH
2
C
Y
119
Orthopedic
Countersink
888.4540
I
HWW
1
C
Y
120
Orthopedic
Drill Bit
888.4540
I
HTW
1
C
Y
121
Orthopedic
Knife
888.4540
I
HTS
1
C
Y
122
Orthopedic
Manual Surgical Instrument
888.4540
I
LXH
1
C
Y
123
Orthopedic
Needle Holder
888.4540
I
HXK
1
C
Y
124
Orthopedic
Reamer
888.4540
I
HTO
1
C
Y
125
Orthopedic
Rongeur
888.4540
I
HTX
1
C
Y
126
Orthopedic
Scissors
888.4540
I
HRR
1
C
Y
127
Orthopedic
Staple Driver
888.4540
I
HXJ
1
C
Y
128
Orthopedic
Trephine
888.4540
I
HWK
1
C
Y
129
Orthopedic
Flexible Reamers/Drills
886.4070
878.4820
I
GEY, HRG
1
C
Y
130
Orthopedic
External Fixation Frame
888.3040
888.3030
II
JEC KTW
KTT
2
N
N
131
Physical
Medicine
Nonheating Lamp for Adjunctive Use Inpatient
Therapy
890.5500
II
NHN
1
N
N
132
Physical
Medicine
Electrode Cable,
890.1175
II
IKD
1
N
Y
133
Physical
Medicine
External Limb Component,
Hip Joint
890.3420
I
ISL
2
N
Y
134
Physical
Medicine
External Limb Component,
Knee Joint
890.3420
I
ISY
2
N
Y
135
Physical
Medicine
External Limb Component,
Mechanical Wrist
890.3420
I
ISZ
2
N
Y
136
Physical
Medicine
External Limb Component,
Shoulder Joint
890.3420
I
IQQ
2
N
Y
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Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued
Medical
Specialty
Regulation
Number
Device Type
Class
Product
Code
RiskA
Critical/
Semicritical/Noncritical
Premarket
Exempt
137
Plastic Surgery
Stapler
878.4800
I
GAG, GEF,
FHM,
HBT
2
C
Y
138
Radiology
Isotope Needle
892.5730
II
IWF
3
C
N
139
Respiratory
Endotracheal Tube Changer
Unclassified
III
LNZ
3
C
N
140
Respiratory
Anesthesia conduction
needle
868.5150
II
BSP
3
C
N
141
Respiratory
Short term spinal needle
868.5150
II
MIA
3
C
N
142
Respiratory
Respiratory Therapy and
Anesthesia Breathing
Circuits
868.5240
I
CAI
2
S
Y
143
Respiratory
Oral and Nasal Catheters
868.5350
I
BZB
1
C
Y
144
Respiratory
Gas Masks
868.5550
I
BSJ
1
S
Y
145
Respiratory
Breathing Mouthpiece
868.5620
I
BYP
1
N
Y
146
Respiratory
Tracheal Tube
868.5730
II
BTR
3
C
N
147
Respiratory
Airway Connector
868.5810
I
BZA
2
S
Y
148
Respiratory
CPAP Mask
868.5905
II
BZD
3
S
N
149
Respiratory
Emergency Manual Resuscitator
868.5915
II
BTM
2
S
N
150
Respiratory
Tracheobronchial Suction
Catheter
868.6810
I
BSY
3
S
Y
151
Surgery
AC-powered Orthopedic
Instrument and accessories
878.4820
I
HWE
2
C
N
152
Surgery
Breast Implant Mammary
Sizer
Unclassified
MRD
1
C
N
153
Surgery
Ultrasonic Surgical Instrument
Unclassified
LFL
3
C
N
154
Surgery
Trocar
874.4420
I
KAB, KBG,
KCI
3
C
Y
155
Surgery
Endoscopic Blades
876.1500
II
GCP, GCR
2
C
N
156
Surgery
Endoscopic Guidewires
876.1500
II
GCP, GCR
1
C
N
157
Surgery
Inflatable External Extremity Splint
878.3900
I
FZF
1
N
Y
158
Surgery
Noninflatable External Extremity Splint
878.3910
I
FYH
1
N
Y
159
Surgery
Catheter needle
878.4200
I
GCB
3
C
Y
160
Surgery
Implantable Clip
878.4300
II
FZP
3
C
N
161
Surgery
Electrosurgical and Coagulation Unit With Accessories
878.4400
II
BWA
2
C
N
162
Surgery
Electrosurgical Apparatus
878.4400
II
HAM
2
C
N
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13:52 Sep 28, 2005
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Fmt 4703
Sfmt 4703
E:\FR\FM\29SEN1.SGM
29SEN1
56923
Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices
Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued
Medical
Specialty
Regulation
Number
Device Type
Class
Product
Code
RiskA
Critical/
Semicritical/Noncritical
Premarket
Exempt
163
Surgery
Electrosurgical Cutting &
Coagulation Device &
Accessories
878.4400
II
GEI
NUJ
2
3
C
N
164
Surgery
Electrosurgical Device
878.4400
II
DWG
2
C
N
165
Surgery
Electrosurgical Electrode
878.4400
II
JOS
2
C
N
166
Surgery
Implantable Staple, Clamp,
Clip for Suturing Apparatus
878.4750
II
GDW
3
C
N
167
Surgery
Percutaneous biopsy device
878.4800
I
MJG
3
C
Y
168
Surgery
Gastro-Urology needle
878.4800
I
FHR
3
C
Y
169
Surgery
Aspiration and injection
needle
878.4800
I
GAA
3
C
Y
170
Surgery
Biopsy Brush
878.4800
I
GEE
1
C
Y
171
Surgery
Blood Lancet
878.4800
I
FMK
1
C
Y
172
Surgery
Bone Hook
878.4800
I
KIK
1
C
Y
173
Surgery
Cardiovascular Biopsy
Needle
878.4800
I
DWO
3
C
Y
174
Surgery
Clamp
878.4800
I
GDJ
1
C
Y
175
Surgery
Clamp
878.4800
I
HXD
1
C
Y
176
Surgery
Curette
878.4800
I
HTF
1
C
Y
177
Surgery
Disposable Surgical Instrument
878.4800
I
KDC
1
C
Y
178
Surgery
Disposable Vein Stripper
878.4800
I
GAJ
1
C
Y
179
Surgery
Dissector
878.4800
I
GDI
1
C
Y
180
Surgery
Forceps
878.4800
I
GEN
2
C
Y
181
Surgery
Forceps
878.4800
I
HTD
2
C
Y
182
Surgery
Gouge
878.4800
I
GDH
1
C
Y
183
Surgery
Hemostatic Clip Applier
878.4800
I
HBT
2
C
Y
184
Surgery
Hook
878.4800
I
GDG
1
C
Y
185
Surgery
Manual Instrument
878.4800
I
MDM,
MDW
1
C
Y
186
Surgery
Manual Retractor
878.4800
I
GZW
1
C
Y
187
Surgery
Manual Saw and Accessories
878.4800
I
GDR HAC
1
C
Y
188
Surgery
Manual Saw and Accessories
878.4800
I
HAC
1
C
Y
189
Surgery
Manual Surgical Chisel
878.4800
I
FZO
1
C
Y
190
Surgery
Mastoid Chisel
878.4800
I
JYD
1
C
Y
191
Surgery
Orthopedic Cutting Instrument
878.4800
I
HTZ
1
C
Y
192
Surgery
Orthopedic Spatula
878.4800
I
HXR
1
C
Y
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Fmt 4703
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E:\FR\FM\29SEN1.SGM
29SEN1
56924
Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices
Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued
Medical
Specialty
Regulation
Number
Device Type
Class
Product
Code
RiskA
Critical/
Semicritical/Noncritical
Premarket
Exempt
193
Surgery
Osteotome
878.4800
I
HWM
1
C
Y
194
Surgery
Rasp
878.4800
I
GAC
1
C
Y
195
Surgery
Rasp
878.4800
I
HTR
1
C
Y
196
Surgery
Retractor
878.4800
I
GAD
1
C
Y
197
Surgery
Retractor
878.4800
I
HXM
1
C
Y
198
Surgery
Saw
878.4800
I
HSO
1
C
Y
199
Surgery
Scalpel Blade
878.4800
I
GES
1
C
Y
200
Surgery
Scalpel Handle
878.4800
I
GDZ
1
C
Y
201
Surgery
Scissors
878.4800
I
LRW
1
C
Y
202
Surgery
Snare
878.4800
I
GAE
1
C
Y
203
Surgery
Spatula
878.4800
I
GAF
1
C
Y
204
Surgery
Staple Applier
878.4800
I
GEF
2
C
Y
205
Surgery
Stapler
878.4800
I
GAG
2
C
Y
206
Surgery
Stomach and Intestinal
Suturing Apparatus
878.4800
I
FHM
2
C
Y
207
Surgery
Surgical Curette
878.4800
I
FZS
1
C
Y
208
Surgery
Surgical Cutter
878.4800
I
FZT
1
C
Y
209
Surgery
Surgical Knife
878.4800
I
EMF
1
S
Y
210
Surgery
Laser Powered Instrument
878.4810
II
GEX
2
C
N
211
Surgery
AC-Powered Motor
878.4820
I
GEY
2
C
Y
212
Surgery
Bit
878.4820
I
GFG
1
C
Y
213
Surgery
Bur
878.4820
I
GFF, GEY
1
C
Y
214
Surgery
Cardiovascular Surgical
Saw Blade
878.4820
I
DWH
1
C
Y
215
Surgery
Chisel (Osteotome)
878.4820
I
KDG
1
C
Y
216
Surgery
Dermatome
878.4820
I
GFD
1
C
Y
217
Surgery
Electrically Powered Saw
878.4820
I
DWI
2
C
Y
218
Surgery
Pneumatic Powered Motor
878.4820
I
GET
2
C
Y
219
Surgery
Pneumatically Powered
Saw
878.4820
I
KFK
2
C
Y
220
Surgery
Powered Saw and Accessories
878.4820
I
HAB
2
C
Y
221
Surgery
Saw Blade
878.4820
I
GFA
1
C
Y
222
Surgery
Nonpneumatic Tourniquet
878.5900
I
GAX
1
N
Y
223
Surgery
Pneumatic Tourniquet
878.5910
I
KCY
1
N
Y
224
Surgery
Endoscopic Staplers
888.4540
I
HXJ
2
C
Y
225
Surgery
Trocar
876.1500
870.1390
II
GCJ, DRC
3
C
N
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Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices
Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued
Medical
Specialty
Regulation
Number
Device Type
Class
Product
Code
RiskA
Critical/
Semicritical/Noncritical
Premarket
Exempt
226
Surgery
Surgical Cutting Accessories
878.4800,
874.4420
I
GDZ, GDX,
GES,
KBQ,
KAS
2
C
Y
227
Surgery
Electrosurgical Electrodes/
Handles/Pencils
876.4300
878.4400
II
HAM, GEI,
FAS
2
C
N
228
Surgery
Scissor Tips
878.4800,
884.4520,
874.4420
I
LRW, HDK,
HDJ,
JZB,
KBD
2
C
Y
229
Surgery
Laser Fiber Delivery Systems
878.4810
874.4500
886.4390
884.4550
886.4690
II
GEX EWG
LLW
HQF
HHR
HQB
1
C
N
ARisk
categorization may be either:
1 = low risk according to RPS
2 = moderate risk according to RPS
3 = high risk according to RPS
3* = high risk due to neurological use
See section II of this document, ‘‘FDA’s Implementation of New Section 510(o) of the Act’’ for methodology and criteria used to identify the
risk.
Dated: September 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–19510 Filed 9–28–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to OMB under the
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer at (301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
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13:52 Sep 28, 2005
Jkt 205001
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Maternal and Child
Health Services Title V Block Grant
Program—Guidance and Forms for the
Title V Application/Annual Report,
OMB No.0915–0172: Revision
The Health Resources and Services
Administration (HRSA) proposes to
revise the Maternal and Child Health
Services Title V Block Grant Program—
Guidance and Forms for the
Application/Annual Report. The
guidance is used annually by the 50
States and 9 jurisdictions in making
application for Block Grants under Title
V of the Social Security Act, and in
preparing the required annual report.
The proposed revisions follow and
build on extensive consultation received
from a workgroup convened to provide
suggestions to improve the guidance
and forms. The proposed revisions are
editorial and technical revisions based
on the experience of the states and
jurisdictions in using the guidance and
forms since 2003.
Two new performance measures were
developed (obesity in children aged 2 to
PO 00000
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5 years; and smoking in the last
trimester of pregnancy) and two existing
performance measures were either
removed entirely (low birth weight) or
incorporated into an existing health
status capacity indicator (eligible
children receiving services under
Medicaid). This will result in no net
increase in the number of performance
measures. In addition, the directions in
the guidance for the Health Systems
Capacity Indicators (HSCI) were
expanded to enhance clarification. This
proposed change will make it easier for
the states to report on these indicators.
The existing electronic system used
by the states to submit their Block Grant
Application and Annual Report has also
been enhanced. First, using the
electronic system, the narrative from the
prior year’s submission is available
online in the system so that the
applicant need only edit those sections
that have changed. This reduces burden
by avoiding duplicating material. For
national performance measures 2–6, the
data obtained from the National Survey
of Children with Special Health Care
Needs are pre-populated which
eliminates the need to retrieve and enter
data from this survey, unless the states
choose to use another data source. Also,
notes from the prior year’s submission
are available to the states allowing for
more efficient updating through edits
rather then recreating them. Data are
entered once (in a data entry field on a
given form), and where those data are
referenced elsewhere, the value is
E:\FR\FM\29SEN1.SGM
29SEN1
]]>Agencies
[Federal Register Volume 70, Number 188 (Thursday, September 29, 2005)]
[Notices]
[Pages 56911-56925]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0161] (formerly Docket No. 03N-0161)
Medical Devices; Reprocessed Single-Use Devices; Termination of
Exemptions From Premarket Notification; Requirement for Submission of
Validation Data
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is adding
noncompression heart stabilizers to the list of critical reprocessed
single-use devices (SUDs) whose exemption from premarket notification
requirements has been terminated and for which validation data, as
specified under the Medical Device User Fee and Modernization Act of
2002 (MDUFMA), are necessary in a premarket notification (510(k)). The
agency is also adding laparoscopic and endoscopic electrosurgical
accessories to the list of reprocessed SUDs currently subject to
premarket notification requirements that will now require submission of
supplemental validation data. FDA is requiring submission of these data
to ensure that reprocessed single-use noncompression heart stabilizers
and laparoscopic and endoscopic electrosurgical accessories are
substantially equivalent to predicate devices, in accordance with
MDUFMA.
DATES: These actions are effective September 29, 2005. Manufacturers of
reprocessed single-use noncompression heart stabilizers must submit
510(k)s for these devices by December 29, 2006, or their devices may no
longer be legally marketed. Manufacturers of reprocessed single-use
laparoscopic and endoscopic electrosurgical accessories who already
have 510(k) clearance for these devices must submit supplemental
validation data for the devices by June 29, 2006, or their devices may
no longer be legally marketed.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.fda.gov/dockets/ecomments. Comments should be identified with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Barbara A. Zimmerman, Center for
Devices and Radiological Health (HFZ-410), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8320, ext. 158.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, MDUFMA (Public Law 107-250), amended the
Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o)
(21 U.S.C. 360(o)), which provided new regulatory requirements for
reprocessed SUDs. According to this new provision, in order to ensure
that reprocessed SUDs are substantially equivalent to predicate
devices, 510(k)s for certain reprocessed SUDs identified by FDA must
include validation data. These required validation data include
cleaning and sterilization data, and functional performance data
demonstrating that each SUD will remain substantially equivalent to its
predicate device after the maximum number of times the device is
reprocessed as intended by the person submitting the premarket
notification.
Before enactment of the new law, a manufacturer of a reprocessed
SUD was required to obtain premarket approval or premarket clearance
for the device, unless the device was exempt from premarket submission
requirements. Under MDUFMA, some previously exempt reprocessed SUDs are
no longer exempt from premarket notification requirements.
Manufacturers of these identified devices were required to submit
510(k)s that included validation data specified by FDA. Reprocessors of
certain SUDs already subject to cleared 510(k)s were also required to
submit the validation data specified by the agency.
The reprocessed SUDs subject to these new requirements were listed
in the Federal Register as required by MDUFMA. In accordance with
section 510(o) of the act, FDA shall revise the lists as appropriate.
This notice adds two types of reprocessed SUDs to the lists of devices
subject to MDUFMA's data submission requirements. Noncompression heart
stabilizers are being added to the list of previously exempt
reprocessed SUDs that now require the submission of 510(k)s containing
validation data. Laparoscopic and endoscopic electrosurgical
accessories are being added to the list of reprocessed SUDs, already
subject to premarket notification requirements, for which supplemental
validation data are required.
A. Definitions
Under section 302(b) of MDUFMA, a reprocessed SUD is defined as an
``original device that has previously been used on a patient and has
been subjected to additional processing and manufacturing for the
purpose of an additional single use on a patient. The subsequent
processing and manufacture of a reprocessed single-use device shall
result in a device that is reprocessed within the meaning of this
definition.''
Reprocessed SUDs are divided into three groups: (1) critical, (2)
semicritical, and (3) noncritical. The first two categories reflect
definitions set forth in MDUFMA, and all three reflect a classification
scheme recognized in the industry.\1\ These categories of devices are
defined as follows:
---------------------------------------------------------------------------
\1\Spaulding, E.H., ``The Role of Chemical Disinfection in the
Prevention of Nonsocomial Infections,'' P.S. Brachman and T.C.
Eickof (ed), Proceedings of International Conference on Nonsocomial
Infections, 1970, American Hospital Association, Chicago, 254-274,
1971.
---------------------------------------------------------------------------
(1) A critical reprocessed SUD is intended to contact normally
sterile tissue or body spaces during use.
(2) A semicritical reprocessed SUD is intended to contact intact
mucous membranes and not penetrate normally sterile areas of the body.
(3) A noncritical reprocessed SUD is intended to make topical
contact and not penetrate intact skin.
B. Critical and Semicritical Reprocessed SUDs Previously Exempt From
Premarket Notification
MDUFMA required FDA to review the critical and semicritical
reprocessed SUDs that were previously exempt from premarket
notification requirements and determine which of these devices required
premarket notification to ensure their substantial equivalence to
predicate devices. By April 26, 2003, FDA was required to identify in a
Federal Register notice those critical reprocessed SUDs whose exemption
from premarket notification would be terminated and for which FDA
determined that validation data, as specified under MDUFMA, was
necessary in a 510(k). According to the law, manufacturers of the
devices whose exemptions from premarket notification were terminated
were required to submit 510(k)s that included validation data regarding
cleaning, sterilization, and functional performance, in addition to all
the other required elements of a 510(k) identified in Sec. 807.87 (21
CFR 807.87), within 15 months of
[[Page 56912]]
publication of the notice or no longer market their devices.
In accordance with section 510(o) of the act, FDA must revise the
list of devices subject to this requirement as appropriate. On June 26,
2003 (68 FR 38071), FDA recategorized nine device types from
semicritical to critical, and added nonelectric gastroenterology-
urology biopsy forceps to the list of critical devices whose exemption
from premarket notification requirements was being terminated.
By April 26, 2004, FDA was required to identify in a Federal
Register notice those semicritical reprocessed SUDs whose exemption
from premarket notification would be terminated and for which FDA
determined that validation data, as specified under MDUFMA, was
necessary in a 510(k). As discussed above, manufacturers of the devices
whose exemptions from premarket notification were terminated were
required to submit 510(k)s that included validation data regarding
cleaning, sterilization, and functional performance, in addition to all
the other required elements of a 510(k) identified in Sec. 807.87,
within 15 months of publication of the notice or no longer market their
devices. In accordance with section 510(o) of the act, FDA must revise
the list of devices subject to this requirement as appropriate.
C. Reprocessed SUDs Already Subject to Premarket Notification
Requirements
MDUFMA also required FDA to review the types of reprocessed SUDs
already subject to premarket notification requirements and to identify
which of these devices required the submission of validation data to
ensure their substantial equivalence to predicate devices. FDA
published a list of these devices in the Federal Register on April 30,
2003 (68 FR 23139). As described above, FDA must revise the list of
devices subject to this requirement as appropriate.
For devices identified on this list that had already been cleared
through the 510(k) process, manufacturers were required to submit
validation data regarding cleaning, sterilization, and functional
performance within 9 months of publication of the list or no longer
market their devices.
For devices on this list that were not yet cleared through the
510(k) process, manufacturers were required to submit 510(k)s including
validation data regarding cleaning, sterilization, and functional
performance, in addition to all the other required elements identified
in 21 CFR 807.87, in order to market these devices.
II. FDA's Implementation of New Section 510(o) of the Act
In the Federal Register of April 30, 2003 (68 FR 23139), FDA
described the methodology and criteria used to identify the reprocessed
SUDs that were included in the lists required by MDUFMA. First, FDA
described how it identified the types of SUDs currently being
reprocessed and how the Spaulding definitions (see footnote 1) were
used to categorize these devices as critical, semicritical, or
noncritical. (See Attachment 1.) Next, the agency described its use of
the Risk Prioritization Scheme (RPS)\2\ that was used to evaluate the
potential risk (high, moderate, or low) associated with an SUD based on
the following factors: (1) Risk of infection and (2) risk of inadequate
performance following reprocessing. FDA identified its final criterion
as those reprocessed SUDs intended to come in contact with tissue at
high risk of being infected with the causative agents of Creutzfeldt-
Jakob Disease (CJD). (These are generally devices intended for use in
neurosurgery and ophthalmology.)
---------------------------------------------------------------------------
\2\This scheme is described in the February 2000 draft guidance
document entitled, ``Reprocessing and Reuse of Single-Use Devices:
Review Prioritization Scheme.'' https://www.fda.gov/cdrh/reuse/
1156.html.
---------------------------------------------------------------------------
Using this methodology and these criteria, the devices included on
List I (Critical and Semicritical Reprocessed SUDs Previously Exempt
from Premarket Notification Requirements that Now Require 510(k)s with
Validation Data) of the April 30, 2003, June 26, 2003, and April 13,
2004, Federal Register notices are those critical and semicritical
reprocessed SUDs that were either high risk according to the RPS or
intended to come in contact with tissue at high risk of being infected
with CJD. The devices included on List II (Reprocessed SUDs Subject to
Premarket Notification Requirements that Now Require the Submission of
Validation Data) of the April 30, 2003, Federal Register notice are
those reprocessed SUDs already subject to premarket notification
requirements that were either high risk according to the RPS or
intended to come in contact with tissue at high risk of being infected
with CJD.
III. Revisions to Attachment 1, List I, and List II
A. Revisions to Attachment 1 (List of SUDs Known To Be Reprocessed or
Considered for Reprocessing)
FDA has evaluated the comments received regarding section 510(o) of
the act. In doing so, the agency has determined that all noncompression
heart stabilizers and endoscopic and laparoscopic electrosurgical
accessories should be considered high risk devices when reprocessed.
Noncompression heart stabilizers are intended to move, lift, and
position the heart while maintaining hemodynamic stability during
cardiovascular surgery. The agency has determined that noncompression
heart stabilizers are high risk devices when reprocessed because they
include features, such as narrow tubing, interlocking parts, and small
crevices that could impede cleaning and sterilization and because these
devices contain materials, coatings, or components that may be damaged
or altered by reprocessing. Therefore, these devices have the potential
for a high risk of infection and/or inadequate performance when
reprocessed. This includes noncompression heart stabilizers (device 21
in Attachment 1) classified under Sec. 870.4500 (21 CFR 870.4500). In
determining that noncompression heart stabilizers are high risk devices
when reprocessed, a new product code has been created to identify these
devices within regulation Sec. 870.4500. The new product code is NQG.
This new product code has been added to device 21 in Attachment 1 of
this document.
Endoscopic and laparoscopic electrosurgical accessories are
surgical instruments used during minimally invasive surgery, including
vein harvesting. The agency has determined that these devices should be
considered high risk devices when reprocessed because they include
features, such as narrow lumens, that could impede thorough cleaning
and sterilization and because these devices contain materials,
coatings, or components that may be damaged or altered by reprocessing.
Therefore, these devices have the potential for a high risk of
infection or inadequate performance when reprocessed. This includes
endoscopic and laparoscopic electrosurgical accessories (device 162 in
Attachment 1) classified under Sec. 878.4400 (21 CFR 878.4400). In
determining that endoscopic and laparoscopic electrosurgical
accessories are potentially high risk devices when reprocessed, a new
product code has been created to identify these devices within
regulation Sec. 878.4400. The new product code is NUJ. This new
product code has been added to device 162 in Attachment 1.
These changes are reflected in a revised version of Attachment 1
included in this Federal Register notice.
[[Page 56913]]
B. Revisions to List I (Critical and Semicritical Reprocessed Single-
Use Devices Previously Exempt from Premarket Notification Requirements
that Now Require 510(k)s with Validation Data)
Using the RPS, FDA has recategorized noncompression heart
stabilizers from moderate risk to high risk when reprocessed, and the
agency has therefore added noncompression heart stabilizers to List I.
Manufacturers of noncompression heart stabilizers will be required to
submit 510(k)s with validation data by December 29, 2006, which is 15
months following this revision of the list.
To help reprocessors be able to easily identify those critical and
semicritical reprocessed SUDs that have been categorized into List I in
this notice and previous Federal Register notices, FDA is re-issuing a
complete listing of these devices. Therefore, List 1 now identifies all
critical and semicritical reprocessed SUDs previously exempt from
premarket notification requirements that now require 510(k)s with
validation data.
C. Revisions to List II (Reprocessed Single-Use Devices Subject to
Premarket Notification Requirements that Now Require the Submission of
Validation Data)
Using the RPS, FDA has recategorized endoscopic and laparoscopic
electrosurgical accessories under regulation Sec. 878.4400 from
moderate risk to high risk when reprocessed. Therefore, endoscopic and
laparoscopic electrosurgical accessories have been added to List II.
Under MDUFMA, manufacturers of these devices who have already obtained
clearance through the 510(k) process must submit validation data
regarding cleaning, sterilization, and functional performance by June
29, 2006, which is 9 months following this revision of the list. Upon
publication of this notice, manufacturers who have not yet obtained
clearance through the 510(k) process must submit 510(k)s including
validation data regarding cleaning, sterilization, and functional
performance, in addition to all the other required elements of a 510(k)
identified in 21 CFR 807.87, in order to market these devices.
List I.--Critical and Semicritical Reprocessed Single-Use Devices
Previously Exempt From Premarket Notification Requirements that Now
Require 510(k)s With Validation Data [Manufacturers of noncompression
heart stabilizers will need to submit 510(k)s with validation data by 15
months following the publication of this revised list.]
------------------------------------------------------------------------
Product code Product code
21 CFR Classification Product code for for name for
No. name nonreprocessed reprocessed reprocessed
device device device
------------------------------------------------------------------------
868.681 Tracheobronchial BSY NQV Tracheobronc
0 suction hial
catheter suction
catheter
------------------------------------------------------------------------
870.450 Cardiovascular MWS NQG Noncompressi
0 surgical on heart
instruments stabilizer
------------------------------------------------------------------------
872.324 Dental bur Diamond coated NME Dental
0 diamond
coated bur
------------------------------------------------------------------------
872.453 Dental diamond DZP NLD Dental
5 instrument diamond
instrument
------------------------------------------------------------------------
872.473 Dental injection DZM NMW Dental
0 needle needle
------------------------------------------------------------------------
872.541 Orthodontic EJF NQS Orthodontic
0 appliance and metal
accessories bracket
------------------------------------------------------------------------
874.414 Ear, nose, and Microdebrider NLY ENT high
0 throat bur speed
microdebrid
er
------------------------------------------------------------------------
874.414 Ear, nose, and Diamond coated NLZ ENT diamond
0 throat bur coated bur
------------------------------------------------------------------------
874.442 Ear, nose, KAB, KBG, KCI NLB Laryngeal,
0 throat manual sinus,
surgical .. tracheal
trocar
------------------------------------------------------------------------
876.107 Gastroenterology- FCL NON Nonelectric
5 urology biopsy biopsy
instrument forceps
------------------------------------------------------------------------
876.468 Ureteral stone FGO, FFL NQT, NQU Flexible and
0 dislodger basket
stone
dislodger
------------------------------------------------------------------------
878.420 Introduction/ GCB NMT Catheter
0 drainage needle
catheter and
accessories
------------------------------------------------------------------------
878.480 Manual surgical MJG NNA Percutaneous
0 instrument biopsy
device
------------------------------------------------------------------------
878.480 Manual surgical FHR NMU Gastro-
0 instrument Urology
needle
------------------------------------------------------------------------
878.480 Manual surgical DWO NLK Cardiovascul
0 instrument for ar biopsy
... .... needle
------------------------------------------------------------------------
878.480 Manual surgical GAA NNC Aspiration
0 instrument and
for... injection
needle
------------------------------------------------------------------------
882.419 Forming/cutting HBS NMN Forming/
0 clip instrument cutting
clip
instrument
------------------------------------------------------------------------
884.173 Laparoscopic HIF NMI Laparoscopic
0 insufflator, .. insufflator
and
accessories
------------------------------------------------------------------------
884.453 OB/GYN HFB NMG Gynecologica
0 specialized l biopsy
manual forceps
instrument
------------------------------------------------------------------------
886.435 Manual HNN NLA Ophthalmic
0 ophthalmic knife
surgical
instrument
------------------------------------------------------------------------
[[Page 56914]]
List II.--Reprocessed Single-Use Devices Subject to Premarket
Notification Requirements That Now Require the Submission of Validation
Data\1\ [Manufacturers of endoscopic and laparoscopic electrosurgical
accessories who already have 510(k) clearance for these devices must
submit validation data by June 29, 2006. Any new 510(k) for this device
type will require validation data upon publication of this document.]
------------------------------------------------------------------------
Product code Product code
21 CFR Classification Product code for for name for
No. name nonreprocessed reprocessed reprocessed
device device device
------------------------------------------------------------------------
Unclass Oocyte MHK NMO Oocyte
ified aspiration aspiration
needles needles
------------------------------------------------------------------------
Unclass Percutaneous LIT NMM Transluminal
ified transluminal peripheral
angioplasty angioplasty
catheter catheter
------------------------------------------------------------------------
Unclass Ultrasonic LFL NLQ Ultrasonic
ified surgical scalpel
instrument
------------------------------------------------------------------------
868.515 Anesthesia BSP NNH Anesthetic
0 conduction conduction
needle needle
(with/
without
introducer)
------------------------------------------------------------------------
868.515 Anesthesia MIA NMR Short term
0 conduction spinal
needle needle
------------------------------------------------------------------------
868.573 Tracheal tube BTR NMA Tracheal
0 tube (with/
without
connector)
------------------------------------------------------------------------
868.590 Noncontinuous BZD NMC Noncontinuou
5 ventilator s
(IPPB) ventilator
(respirator
) mask
------------------------------------------------------------------------
870.120 Diagnostic DQO NLI Angiography
0 intravascular catheter
catheter
------------------------------------------------------------------------
870.122 Electrode DRF NLH Electrode
0 Recording recording
Catheter catheter
------------------------------------------------------------------------
870.122 Electrode MTD NLG Intracardiac
0 Recording mapping
Catheter catheter
------------------------------------------------------------------------
870.123 Fiberoptic DQE NMB Fiberoptic
0 oximeter oximeter
catheter catheter
------------------------------------------------------------------------
870.128 Steerable DRA NKS Steerable
0 Catheter Catheter
------------------------------------------------------------------------
870.129 Steerable DXX NKR Steerable
0 catheter catheter
control system control
system
------------------------------------------------------------------------
870.133 Catheter guide DQX NKQ Catheter
0 wire guide wire
------------------------------------------------------------------------
870.139 Trocar DRC NMK Cardiovascul
0 ar trocar
------------------------------------------------------------------------
870.165 Angiographic DXT NKT Angiographic
0 injector and injector
syringe and syringe
------------------------------------------------------------------------
870.167 Syringe actuator DQF NKW Injector for
0 for injector actuator
syringe
------------------------------------------------------------------------
870.270 Oximeter MUD NMD Tissue
0 saturation
oximeter
------------------------------------------------------------------------
870.270 Oximeter DQA NLF Oximeter
0
------------------------------------------------------------------------
870.353 Intra-aortic DSP NKO Intra-aortic
5 balloon and balloon and
control system control
system
------------------------------------------------------------------------
870.445 Vascular clamp DXC NMF Vascular
0 clamp
------------------------------------------------------------------------
870.488 External vein DWQ NLJ External
5 stripper vein
stripper
------------------------------------------------------------------------
872.547 Orthodontic DYW NLC Orthodontic
0 Plastic Bracket Plastic
Bracket
------------------------------------------------------------------------
874.468 Bronchoscope BWH NLE Bronchoscope
0 (flexible or (nonrigid)
rigid) and biopsy
accessories forceps
------------------------------------------------------------------------
876.107 Gastro-Urology FCG NMX G-U biopsy
5 biopsy needle and
instrument needle set
------------------------------------------------------------------------
876.107 Gastroenterology- KNW NLS Biopsy
5 urology biopsy instrument
instrument
------------------------------------------------------------------------
876.150 Endoscope and FBK, FHP NMY Endoscopic
0 accessories needle
------------------------------------------------------------------------
876.150 Endoscope and MPA NKZ Endoillumina
0 accessories tor
------------------------------------------------------------------------
876.150 Endoscope and GCJ NLM General and
0 accessories plastic
surgery
laparoscope
------------------------------------------------------------------------
[[Page 56915]]
876.150 Endoscope and FHO NLX Spring-
0 accessories loaded
pneumoperit
oneum
needle
------------------------------------------------------------------------
876.430 Endoscopic FAS NLW Active
0 electrosurgical Urological
unit and electrosurg
accessories ical
electrode
------------------------------------------------------------------------
876.430 Endoscopic FEH NLV Flexible
0 electrosurgical suction
unit and coagulator
accessories electrode
------------------------------------------------------------------------
876.430 Endoscopic KGE NLU Electric
0 electrosurgical biopsy
unit and forceps
accessories
------------------------------------------------------------------------
876.430 Endoscopic FDI NLT Flexible
0 electrosurgical snare
unit and
accessories
------------------------------------------------------------------------
876.430 Endoscopic KNS NLR Endoscopic
0 electrosurgical (with or
unit and without
accessories accessories
)
Electrosurg
ical unit
------------------------------------------------------------------------
876.501 Biliary catheter FGE NML Biliary
0 and accessories catheter
------------------------------------------------------------------------
876.554 Blood access LBW NNF Single
0 device and needle
accessories dialysis
set (co-
axial flow)
------------------------------------------------------------------------
876.554 Blood access FIE NNE Fistula
0 device and needle
accessories
------------------------------------------------------------------------
876.582 Hemodialysis FIF NNG Single
0 systems and needle
accessories dialysis
set with
uni-
directional
pump
------------------------------------------------------------------------
878.430 Implantable clip FZP NMJ Implantable
0 clip
------------------------------------------------------------------------
878.440 Electrosurgical GEI NUJ Endoscopic
0 Cutting and and
Coagulation laparoscopi
Device and c
Accessories electrosurg
ical
accessories
------------------------------------------------------------------------
878.475 Implantable GDW NLL Implantable
0 staple staple
------------------------------------------------------------------------
880.557 Hypodermic FMI NKK Hypodermic
0 single lumen single
needle lumen
needle
------------------------------------------------------------------------
880.586 Piston Syringe FMF NKN Piston
0 Syringe
------------------------------------------------------------------------
882.430 Manual cranial HBG NLO (Manual)
0 drills, burrs, drills,
trephines and burrs,
accessories trephines
and
accessories
------------------------------------------------------------------------
882.430 Powered compound HBF NLP (Powered,
5 cranial drills, compound)
burrs, drills,
trephines . burrs,
trephines
and
accessories
------------------------------------------------------------------------
882.431 Powered simple HBE NLN (Simple,
0 cranial drills, powered)
burrs, drills,
trephines . burrs,
trephines
and
accessories
------------------------------------------------------------------------
884.172 Gynecologic HET NMH Gynecologic
0 laparoscope and laparoscope
accessories (and
accessories
)
------------------------------------------------------------------------
884.610 Assisted MQE NNB Assisted
0 reproduction reproductio
needle n needle
------------------------------------------------------------------------
886.437 Keratome HMY, HNO NKY Keratome
0 blade
------------------------------------------------------------------------
886.467 Phacofragmentati HQC NKX Phacoemulsif
0 on system ication
needle
------------------------------------------------------------------------
892.573 Radionuclide IWF NMP Isotope
0 brachytherapy needle
source
------------------------------------------------------------------------
\1\Hemodialyzers have been excluded from this list because the reuse of
hemodialyzers is addressed in ``Draft Guidance for Hemodialyzer Reuse
Labeling'' October 6, 1995. An archived copy may be obtained from
CDRH's Division of Small Manufacturers, International, and Consumer
Assistance, please contact dsmica@cdrh.fda.gov.
[[Page 56916]]
IV. Stakeholder Input
In the Federal Register of February 4, 2003 (68 FR 5643), FDA
invited interested persons to provide information and share views on
the implementation of MDUFMA. Since that time, the agency has received
comments on various MDUFMA provisions, including several on its
implementation of section 510(o) of the act. As discussed above, one
comment recommended that heart stabilizers should be considered high
risk because of the risk of cross contamination and deterioration of
the mechanical properties of the device. FDA agrees that noncompression
heart stabilizers, a subset of all heart stabilizers, should be added
to the list of critical reprocessed SUDs previously exempt from
premarket notification requirements that will now require 510(k)s with
validation data. Therefore, FDA has added noncompression heart
stabilizers to List I.
Another comment recommended that FDA recategorize endoscopic vessel
harvesting devices as high risk to be consistent with the
categorization of other endoscopic accessories under 21 CFR 876.1500
(Endoscope and accessories). FDA agrees that endoscopic vessel
harvesting devices should be considered high risk and subject to the
submission of validation data. As discussed previously, in reviewing
this comment, the agency also determined that laparoscopic
electrosurgical accessories should be similarly categorized. Therefore,
FDA has added laparoscopic and endoscopic electrosurgical accessories
to List II.
Other additional comments requested that specific reprocessed SUDs
be added to either List I or II. Each of these comments was carefully
considered. However, FDA does not believe, based on the risk-based
approach described in the April 30, 2003, Federal Register notice, that
SUDs other than those identified in this notice should be added to the
Lists at this time.
Another comment requested the FDA to call for the immediate
submission and review of validation data regarding cleaning,
sterilization, and functional performance for all reprocessed SUDs. The
comment further stated that this request was based on the significant
number of reprocessed devices which were withdrawn or were deemed to be
insufficiently supported by validation data as of February 8, 2005.
Section 510(o) of the act required FDA to identify those
reprocessed SUDs for which validation data must be submitted in order
to ensure that those SUDs remain substantially equivalent to predicate
devices after reprocessing. Because the agency has found that some
reprocessed SUDs do not require the submission and review of validation
data in order to demonstrate substantial equivalence, the agency
identified the types of devices requiring the submission of validation
data by implementing a risk-based approach. This risk-based approach,
described in the April 30, 2003, Federal Register notice, identified a
significant number of reprocessed SUDs that can no longer be legally
marketed without agency review and clearance of validation data. The
failure of some manufacturers to submit this validation data and the
agency's review of submitted data resulted in a determination that a
significant number of reprocessed SUDs could no longer be legally
marketed. However, the process also identified a significant number of
reprocessed SUDs that could continue to be marketed because: (1) they
were found not to require the submission of additional validation data
in order to ensure substantial equivalence to legally marketed
predicate devices; or (2) after a review of submitted validation data,
they were found to be substantially equivalent to legally marketed
predicate devices. Therefore, FDA does not intend to expand the list of
reprocessed SUDs subject to the submission and review of validation
data to all reprocessed SUDs as requested in the comment. The agency
believes it has implemented section 510(o) of the act by identifying
the types of devices that require the submission of validation data and
determining which of those devices can no longer be legally marketed.
V. Comments
You may submit written or electronic comments on the designation of
reprocessed noncompression heart stabilizers and laparoscopic and
endoscopic electrosurgical devices requiring the submission of
premarket notifications with validation data to the Division of Dockets
Management (see ADDRESSES). Submit electronic comments to https://
www.fda.gov/dockets/ecomments. Submit two copies of mailed comments,
but individuals may submit one copy. You should identify your comments
with the docket number found in brackets in the heading of this
document. You may see any comments FDA receives in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing
----------------------------------------------------------------------------------------------------------------
Critical/
Medical Device Type Regulation Class Product Risk\A\ Semicritical/ Premarket
Specialty Number Code Noncritical Exempt
----------------------------------------------------------------------------------------------------------------
1 Cardio Cardiopulmo Unclassified ........ MAB 1 C N
nary
Bypass
Marker
----------------------------------------------------------------------------------------------------------------
2 Cardio Percutaneou Post- III LOX 3 C N
s & amendment
Operative
Translumin
al
Coronary
Angioplast
y Catheter
(PTCA)
----------------------------------------------------------------------------------------------------------------
3 Cardio Percutaneou Post- III LPB 3 C N
s Ablation amendment
Electrode
----------------------------------------------------------------------------------------------------------------
4 Cardio Peripheral 870.1250 II LIT 3 C N
Translumin
al
Angioplast
y (PTA)
Catheter
----------------------------------------------------------------------------------------------------------------
5 Cardio Blood- 870.1120 II DXQ 1 N N
Pressure
Cuff
----------------------------------------------------------------------------------------------------------------
6 Cardio Angiography 870.1200 II DQO 3 C N
Catheter
----------------------------------------------------------------------------------------------------------------
[[Page 56917]]
7 Cardio Electrode 870.1220 II DRF 3 C N
Recording
Catheter
----------------------------------------------------------------------------------------------------------------
8 Cardio High- 870.1220 II MTD 3 C N
Density
Array
Catheter
----------------------------------------------------------------------------------------------------------------
9 Cardio Fiberoptic 870.1230 II DQE 3 C N
Oximeter
Catheter
----------------------------------------------------------------------------------------------------------------
10 Cardio Steerable 870.1280 II DRA 3 C N
Catheter
----------------------------------------------------------------------------------------------------------------
11 Cardio Steerable 870.1290 II DXX 3 C N
Catheter
Control
System
----------------------------------------------------------------------------------------------------------------
12 Cardio Guide Wire 870.1330 II DQX 3 C N
----------------------------------------------------------------------------------------------------------------
13 Cardio Angiographi 870.1390 II DRC 3 C N
c Needle
----------------------------------------------------------------------------------------------------------------
14 Cardio Trocar 870.1390 II DRC 3 C N
----------------------------------------------------------------------------------------------------------------
15 Cardio Syringes 870.1650 II DXT 3 C N
----------------------------------------------------------------------------------------------------------------
16 Cardio Injector 870.1670 II DQF 3 C N
Type
Syringe
Actuator
----------------------------------------------------------------------------------------------------------------
17 Cardio Oximeter 870.2700 II DQA 3 N N
----------------------------------------------------------------------------------------------------------------
18 Cardio Tissue 870.2700 II MUD 3 C N
Saturation
Oximeter
----------------------------------------------------------------------------------------------------------------
19 Cardio Intra- 870.3535 III DSP 3 C N
Aortic
Balloon
System
----------------------------------------------------------------------------------------------------------------
20 Cardio Vascular 870.4450 II DXC 3 C N
Clamp
----------------------------------------------------------------------------------------------------------------
21 Cardio Heart 870.4500 I MWS 2 C Y
Stabilizer
----------------------------------------------------------------------------------------------------------------
22 Cardio Noncompress 870.4500 I MWS 3 C Y
ion Heart
Stabilizer
----------------------------------------------------------------------------------------------------------------
23 Cardio External 870.4885 II DWQ 3 C N
Vein
Stripper
----------------------------------------------------------------------------------------------------------------
24 Cardio Compressibl 870.5800 II JOW 1 N N
e Limb
Sleeve
----------------------------------------------------------------------------------------------------------------
25 Dental Bur 872.3240 I EJL 1 C Y
----------------------------------------------------------------------------------------------------------------
26 Dental Diamond 872.3240 I EJL 3 C Y
Coated Bur
----------------------------------------------------------------------------------------------------------------
27 Dental Diamond 872.4535 I DZP 3 C Y
Instrument
----------------------------------------------------------------------------------------------------------------
28 Dental AC-Powered 872.4120 II DZH 2 C N
Bone Saw
----------------------------------------------------------------------------------------------------------------
29 Dental Manual Bone 872.4120 II DZJ 2 C N
Drill and
Wire
Driver
----------------------------------------------------------------------------------------------------------------
30 Dental Powered 872.4120 II DZI 2 C N
Bone Drill
----------------------------------------------------------------------------------------------------------------
31 Dental Intraoral 872.4130 I DZA 1 C Y
Drill
----------------------------------------------------------------------------------------------------------------
32 Dental Injection 872.4730 I DZM 3 C Y
needle
----------------------------------------------------------------------------------------------------------------
33 Dental Metal 872.5410 I EJF 3 S Y
Orthodonti
c Bracket
----------------------------------------------------------------------------------------------------------------
34 Dental Plastic 872.5470 II DYW 3 S N
Orthodonti
c Bracket
----------------------------------------------------------------------------------------------------------------
35 ENT Bur 874.4140 I EQJ 1 C Y
----------------------------------------------------------------------------------------------------------------
36 ENT Diamond 874.4140 I EQJ 3 C Y
Coated Bur
----------------------------------------------------------------------------------------------------------------
37 ENT Microdebrid 874.4140 I EQJ 3 C Y
er
----------------------------------------------------------------------------------------------------------------
[[Page 56918]]
38 ENT Microsurgic 874.4490 II LMS 1 S N
al Argon
Fiber
Optic
Laser
Cable, For
Uses Other
Than
Otology,
Including
Laryngolog
y &
General
Use In
Otolaryngo
logy
----------------------------------------------------------------------------------------------------------------
39 ENT Microsurgic 874.4490 II LXR 1 S N
al Argon
Fiber
Optic
Laser
Cable, For
Use In
Otology
----------------------------------------------------------------------------------------------------------------
40 ENT Microsurgic 874.4500 II EWG 1 S N
al Carbon-
Dioxide
Fiber
Optic
Laser
Cable
----------------------------------------------------------------------------------------------------------------
41 ENT Bronchoscop 874.4680 II BWH 3 C N
e Biopsy
Forceps
(Nonrigid)
----------------------------------------------------------------------------------------------------------------
42 ENT Bronchoscop 874.4680 II JEK 1 C N
e Biopsy
Forceps
(Rigid)
----------------------------------------------------------------------------------------------------------------
43 Gastro/ Biopsy 876.1075 I FFF 1 C Y
Urology Forceps
Cover
----------------------------------------------------------------------------------------------------------------
44 Gastro/ Biopsy 876.1075 II KNW 3 C N
Urology Instrument
----------------------------------------------------------------------------------------------------------------
45 Gastro/ Biopsy 876.1075 II FCG 3 C N
Urology Needle Set
----------------------------------------------------------------------------------------------------------------
46 Gastro/ Biopsy 876.1075 II FCI 2 C N
Urology Punch
----------------------------------------------------------------------------------------------------------------
47 Gastro/ Mechanical 876.1075 II FCF 2 C N
Urology Biopsy
Instrument
----------------------------------------------------------------------------------------------------------------
48 Gastro/ Nonelectric 876.1075 I FCL 3 C Y
Urology Biopsy
Forceps
----------------------------------------------------------------------------------------------------------------
49 Gastro/ Cytology 876.1500 II FDX 2 S N
Urology Brush For
Endoscope
----------------------------------------------------------------------------------------------------------------
50 Gastro/ Endoscope 876.1500 II KOG 2 S N
Urology accessorie
s
----------------------------------------------------------------------------------------------------------------
51 Gastro/ Extraction 876.1500 II KOG 2 S N
Urology Balloons/
Baskets
----------------------------------------------------------------------------------------------------------------
52 Gastro/ Endoscopic 876.1500 II FBK 3 C N
Urology needle
----------------------------------------------------------------------------------------------------------------
53 Gastro/ Simple 876.1500 II FHP 3 C N
Urology Pneumoperi
toneum
Needle
----------------------------------------------------------------------------------------------------------------
54 Gastro/ Spring 876.1500 II FHO 3 C N
Urology Loaded
Pneumoperi
toneum
Needle
----------------------------------------------------------------------------------------------------------------
55 Gastro/ Active 876.4300 II FAS 3 S N
Urology Electrosur
gical
Electrode
----------------------------------------------------------------------------------------------------------------
56 Gastro/ Biliary 876.5010, II FGE 3 C N
Urology Sphinctero 876.1500
tomes
----------------------------------------------------------------------------------------------------------------
57 Gastro/ Electric 876.4300 II KGE 3 C N
Urology Biopsy
Forceps
----------------------------------------------------------------------------------------------------------------
58 Gastro/ Electrosurg 876.4300 II KNS 3 S N
Urology ical
Endoscopic
Unit (With
Or Without
Accessorie
s)
----------------------------------------------------------------------------------------------------------------
[[Page 56919]]
59 Gastro/ Flexible 876.4300 II FDI 3 S N
Urology Snare
----------------------------------------------------------------------------------------------------------------
60 Gastro/ Flexible 876.4300 II FEH 3 S N
Urology Suction
Coagulator
Electrode
----------------------------------------------------------------------------------------------------------------
61 Gastro/ Flexible 876.4680 II FGO 3 S Y
Urology Stone
Dislodger
----------------------------------------------------------------------------------------------------------------
62 Gastro/ Metal Stone 876.4680 II FFL 3 S Y
Urology Dislodger
------------------------------------------------------------------------------------------------------
