Medical Devices; Exemptions From Premarket Notification: Class I Devices, 17841-17844 [2017-07468]
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Federal Register / Vol. 82, No. 70 / Thursday, April 13, 2017 / Notices
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FOR FURTHER INFORMATION CONTACT:
Regarding human food issues: Jason
Dietz, Center for Food Safety and
Applied Nutrition (HFS–205), Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2282.
Regarding animal food issues:
Kathleen Jones, Center for Veterinary
Medicine (HFV–220), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5938.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 19, 2017, we
published a notice announcing the
establishment of a docket to receive
comments on the use of genome editing
techniques to produce new plant
varieties that are used for human or
animal food. We requested these
comments because we recognize that
developers of new plant varieties,
researchers, and other stakeholders may
have valuable factual information and
data about foods derived from new plant
varieties produced using genome
editing, which can help inform FDA’s
thinking for these specific products. The
notice also discussed the history of
FDA’s thinking regarding these
products, our long history of
consultations with developers,
researchers, and other stakeholders, and
specific questions and issues for which
we invited comments. We provided a
90-day comment period that was
scheduled to end on April 19, 2017.
We have received requests for a 60day extension of the comment period.
The requests conveyed concern that the
current 90-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful comments to
the questions and issues we presented
in the notice.
We have considered the requests and
are extending the comment period for
60 days, until June 19, 2017. A 60-day
extension allows more time for
interested persons to submit comments
to the docket on this issue.
Dated: April 7, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–07469 Filed 4–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1610]
Medical Devices; Exemptions From
Premarket Notification: Class I Devices
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
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ACTION:
17841
Notice.
The Food and Drug
Administration (FDA or Agency) has
identified a list of class I devices that
are now exempt from premarket
notification requirements, subject to
certain limitations. FDA is publishing
this notice of that determination in
accordance with procedures established
by the 21st Century Cures Act. This
notice represents FDA’s final
determination with respect to the class
I devices included in this document.
FDA’s action will decrease regulatory
burdens on the medical device industry
and will eliminate private costs and
expenditures required to comply with
certain Federal regulation.
FOR FURTHER INFORMATION CONTACT:
Bryce Bennett, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring,
MD 20993, 301–348–1446, email:
Gregory.Bennett@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Under section 513 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must
classify devices into one of three
regulatory classes: Class I, class II, or
class III. FDA classification of a device
is determined by the amount of
regulation necessary to provide a
reasonable assurance of safety and
effectiveness. Under the Medical Device
Amendments of 1976 (1976
amendments) (Pub. L. 94–295), and the
Safe Medical Devices Act of 1990 (Pub.
L. 101–629), devices are classified into
class I (general controls) if there is
information showing that the general
controls of the FD&C Act are sufficient
to assure safety and effectiveness; into
class II (special controls), if general
controls, by themselves, are insufficient
to provide reasonable assurance of
safety and effectiveness, but there is
sufficient information to establish
special controls to provide such
assurance; and into class III (premarket
approval), if there is insufficient
information to support classifying a
device into class I or class II and the
device is a life sustaining or life
supporting device, or is for a use which
is of substantial importance in
preventing impairment of human
health, or presents a potential
unreasonable risk of illness or injury.
Most generic types of devices that
were on the market before the date of
the 1976 amendments (May 28, 1976)
(generally referred to as preamendments
devices) have been classified by FDA
under the procedures set forth in section
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Federal Register / Vol. 82, No. 70 / Thursday, April 13, 2017 / Notices
513(c) and (d) of the FD&C Act through
the issuance of classification regulations
into one of these three regulatory
classes. Devices introduced into
interstate commerce for the first time on
or after May 28, 1976 (generally referred
to as postamendments devices), are
classified through the premarket
notification process under section
510(k) of the FD&C Act (21 U.S.C.
360(k)). Section 510(k) of the FD&C Act
and the implementing regulations, part
807 of Title 21 of the Code of Federal
Regulations (CFR), require persons who
intend to market a new device to submit
a premarket notification (510(k))
containing information that allows FDA
to determine whether the new device is
‘‘substantially equivalent’’ within the
meaning of section 513(i) of the FD&C
Act to a legally marketed device that
does not require premarket approval.
The 21st Century Cures Act (Pub. L.
114–255) was signed into law on
December 13, 2016. Section 3054 of that
Act amended section 510(l) of the FD&C
Act. As amended, section 510(l)(2) of
the FD&C Act requires FDA to identify
through publication in the Federal
Register, any type of class I device that
the Agency determines no longer
requires a report under section 510(k) of
the FD&C Act to provide reasonable
assurance of safety and effectiveness.
FDA is required to publish this
determination within 120 days of the
date of enactment of the 21st Century
Cures Act and at least once every 5
years thereafter, as FDA determines
appropriate. Section 510(l)(2) further
provides that upon the date of
publication of the Agency’s
determination in the Federal Register, a
510(k) will no longer be required for
these devices and the classification
regulation applicable to each such type
of device shall be deemed amended to
incorporate such exemption. In a final
action, FDA intends to amend the
codified language for each listed
classification regulation to reflect the
final determination with respect to
510(k) exemption. FDA’s action will
decrease regulatory burdens on the
medical device industry and will
eliminate private costs and expenditures
required to comply with certain Federal
regulation. Specifically, regulated
industry will no longer have to invest
time and resources in 510(k)
submissions for certain class I devices,
including preparation of documents and
data for submission to FDA, payment of
user fees associated with 510(k)
submissions, and responding to
questions and requests for additional
information from FDA during 510(k)
review.
II. Criteria for Exemption
As stated previously, section 3054 of
the 21st Century Cures Act amended
section 510(l) of the FD&C Act. In doing
so, the amendments reorganized section
510(l) into subsections 510(l)(1) and (2).
As such, subsection 510(l)(1) provides
that a class I device is exempt from the
premarket notification requirements
under section 510(k) of the FD&C Act,
unless the device is intended for a use
which is of substantial importance in
preventing impairment of human health
or it presents a potential unreasonable
risk of illness or injury (hereafter
‘‘reserved criteria’’). Based on these
reserved criteria, FDA has evaluated all
class I devices to determine which
device types should be exempt from
premarket notification requirements. In
developing the list of exempt devices,
the Agency considered its experience in
reviewing premarket notifications for
these devices, focusing on the risk
inherent with the device and the disease
being treated or diagnosed (e.g., devices
with rapidly evolving technology or
expansions of intended uses). The
Agency also considered the history of
adverse event reports under the medical
device reporting program for these
devices, as well as their history of
product recalls. Following these
considerations, FDA reached the final
determination that the devices listed in
table 1 do not meet the reserved criteria
in that they are not intended for a use
that is of substantial importance in
preventing impairment of human health
or present a potential unreasonable risk
of illness or injury.
III. Limitations on Exemptions
FDA believes that the types of class I
devices listed in this notice should be
exempt from the premarket notification
requirements found under section
510(k) of the FD&C Act. However, an
exemption from the requirement of
premarket notification does not mean
that the device is exempt from any other
statutory or regulatory requirements,
unless such exemption is explicitly
provided by order or regulation. FDA’s
determination that premarket
notification is unnecessary to provide a
reasonable assurance of safety and
effectiveness for devices listed in this
document is based, in part, on the
assurance of safety and effectiveness
that other regulatory controls, such as
current good manufacturing practice
requirements, provide.
In addition to being subject to the
general limitations to the exemptions
found in 21 CFR 862.9, 864.9, 866.9,
872.9, 876.9, 878.9, 880.9, 882.9, 884.9
and 886.9, FDA may also partially limit
the exemption from premarket
notification requirements to specific
devices within a listed device type. In
table 1, for example, FDA lists the
exemption of the ataxiagraph device as
510(k) exempt, but limits the exemption
to such devices that do not provide an
interpretation or a clinical implication
of the measurement. All other
ataxiagraph devices are still subject to
premarket notification requirements
because FDA determined that premarket
notification is necessary to provide a
reasonable assurance of safety and
effectiveness for these devices.
IV. List of Class I Devices
FDA is identifying the following list
of class I devices that no longer require
premarket notification under section
510(k) of the FD&C Act, subject to the
general limitations to the exemptions:
TABLE 1—CLASS I DEVICES
asabaliauskas on DSK3SPTVN1PROD with NOTICES
21 CFR section
862.1410
862.1410
862.1410
862.1410
862.1415
862.1415
...........
...........
...........
...........
...........
...........
862.1415 ...........
862.1415 ...........
862.1415 ...........
VerDate Sep<11>2014
Product
code
Device type
Bathophenanthroline, Colorimetry, Iron (Non-Heme) ......
Photometric Method, Iron (Non-Heme) ............................
Atomic Absorption, Iron (Non-Heme) ...............................
Radio-Labeled Iron Method, Iron (Non-Heme) ................
Ferrozine (Colorimetric) Iron Binding Capacity ................
Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry,
Iron Binding Capacity.
Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron
Binding Capacity.
Bathophenanthroline, Iron Binding Capacity ...................
Radiometric, Fe59, Iron Binding Capacity .......................
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(if applicable)
CFM
JIY
JIZ
JJA
JMO
JQD
JQE
JQF
JQG
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Federal Register / Vol. 82, No. 70 / Thursday, April 13, 2017 / Notices
TABLE 1—CLASS I DEVICES—Continued
21 CFR section
862.1580
862.1660
862.1660
862.1660
862.1660
862.1660
...........
...........
...........
...........
...........
...........
Product
code
Device type
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Electrolyte Controls (Assayed and Unassayed) ..............
Controls For Blood-Gases, (Assayed and Unassayed) ...
Enzyme Controls (Assayed and Unassayed) ..................
Urinalysis Controls (Assayed and Unassayed) ...............
Single (Specified) Analyte Controls (Assayed and
Unassayed).
Multi-Analyte Controls, All Kinds (Assayed) ....................
CEO
JJR
JJS
JJT
JJW
JJX
LCH
862.1660 ...........
Tonometer (Calibration and Q.C. of Blood-Gas Instruments), Clinical.
Kit, Serological, Positive Control ......................................
MJX
862.1660 ...........
Kit, Serological, Negative Control ....................................
MJY
862.1660 ...........
Kit, Direct Antigen, Positive Control .................................
MJZ
862.1660 ...........
Kit, Direct Antigen, Negative Control ...............................
MKA
862.1775
862.1775
862.1775
862.1775
862.1775
862.3050
862.3220
CDH
CDO
JHA
JHC
LFQ
DJZ
JKS
OVR
PRN
LZB
KZF
PEQ
KMJ
BRT
FMQ
OYS
GWW
HCD
GYK
NUQ
NUR
862.1660 ...........
862.1660 ...........
...........
...........
...........
...........
...........
...........
...........
862.3240
862.3280
862.3280
862.3280
862.3280
862.3280
862.3280
862.3280
862.3280
862.3280
862.3280
862.3280
864.7040
864.7040
866.2900
872.4565
872.4565
876.5160
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
878.4014
880.5680
880.6250
880.6320
880.6320
880.6375
880.6760
880.6760
880.6760
882.1030
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
Acid, Uric, Phosphotungstate Reduction .........................
Acid, Uric, Uricase (U.V.) .................................................
Acid, Uric, Uricase (Gasometric) .....................................
Acid, Uric, Uricase (Oxygen Rate) ...................................
Acid, Uric, Acid Reduction of Ferric Ion ..........................
Devices, Breath Trapping, Alcohol ..................................
Spectral
Absorb.
Curve,
Oxyhemoglobin,
Carboxyhemoglobin, Carbon-Monoxide.
Gas Chromatograph, Carbon-Monoxide ..........................
Enzyme Immunoassasy, Nocotine and Nicotine Metabolites.
Cholinesterase Test Paper ..............................................
Colorimetry, Cholinesterase .............................................
Acetylcholine Chloride, Specific Reagent for Pseudo
Cholinesterase.
Solution, M-Nitrophenol, Specific Reagent for Cholinesterase.
Electrometry, Cholinesterase ...........................................
Heavy Metals Control Materials .......................................
Drug Mixture Control Materials ........................................
Digitoxin Control Serum, Ria ...........................................
Alcohol Control Materials .................................................
Digoxin Control Serum, Ria .............................................
Drug Specific Control Materials .......................................
Theophylline Control Materials ........................................
Lidocaine Control Materials .............................................
Methotrexate Control Materials ........................................
N-Acetylprocainamide Control Materials ..........................
Procainamide Control Materials .......................................
ATP Release (Luminescence) .........................................
Adenine Nucleotide Quantitation .....................................
Device, Parasite Concentration .......................................
Parallelometer ..................................................................
Syringe, Irrigating (Dental) ...............................................
External Urethral Occluder, Urinary Incontinence-Control, Female.
Kit, First Aid, Talking ........................................................
Pediatric Position Holder ..................................................
Finger Cot ........................................................................
Device, Medical Examination, AC Powered ....................
Accessories to Examination Light ....................................
Lubricant, Patient .............................................................
Restraint, Patient, Conductive .........................................
Restraint, Protective .........................................................
Patient Bed with Canopy/Restraints ................................
Ataxiagraph ......................................................................
882.4060
882.4545
884.5435
884.5435
...........
...........
...........
...........
Cannula, Ventricular .........................................................
Instrument, Shunt System Implantation ...........................
Pad, Menstrual, Reusable ................................................
Pad, Interlabial .................................................................
862.3220 ...........
862.3220 ...........
862.3240 ...........
862.3240 ...........
862.3240 ...........
862.3240 ...........
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Partial exemption limitation
(if applicable)
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Exemption is limited to controls not intended for use in
donor screening tests.
Exemption is limited to controls not intended for use in
donor screening tests.
Exemption is limited to controls
donor screening tests.
Exemption is limited to controls
donor screening tests.
Exemption is limited to controls
donor screening tests.
Exemption is limited to controls
donor screening tests.
not intended for use in
not intended for use in
not intended for use in
not intended for use in
JKT
MKU
DIG
DIH
DLI
DMR
DOH
DIE
DIF
DJK
DKC
DMP
LAS
LAW
LAX
LAY
LAZ
LBA
JWR
KHF
LKS
EGI
EIB
MNG
Sfmt 4703
Exemption is limited to ataxiagraph devices not intended to provide an interpretation or a clinical implication of the measurement.
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TABLE 1—CLASS I DEVICES—Continued
21 CFR section
886.4070
886.4070
886.4070
886.4070
886.4070
...........
...........
...........
...........
...........
Product
code
Device type
Engine, Trephine, Accessories, Gas-powered ................
Burr, Corneal, Battery-powered .......................................
Engine, Trephine, Accessories, Battery-powered ............
Engine, Trephine, Accessories, AC-powered ..................
Burr, Corneal, AC-powered ..............................................
Dated: April 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
HLD
HOG
HRF
HRG
HQS
HHS.
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Notice of availability; extension
of comment period.
Written/Paper Submissions
[FR Doc. 2017–07468 Filed 4–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0394]
Regulation of Intentionally Altered
Genomic DNA in Animals; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
ACTION:
The Food and Drug
Administration (FDA or we) is
extending the comment period for the
draft guidance for industry (GFI) #187
entitled ‘‘Regulation of Intentionally
Altered Genomic DNA in Animals’’ that
was announced in the Federal Register
of January 19, 2017. We are taking this
action in response to requests for an
extension to allow interested persons
additional time to submit comments.
DATES: We are extending the comment
period on the draft guidance published
January 19, 2017 (82 FR 6561). Although
you can comment on any guidance at
any time (see 21 CFR 10.115(g)(5)), to
ensure that we consider your comment
on this draft guidance, submit either
electronic or written comments on the
draft guidance by June 19, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
VerDate Sep<11>2014
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Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2008–D–0394 for ‘‘Regulation of
Intentionally Altered Genomic DNA in
Animals.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
PO 00000
Frm 00051
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Partial exemption limitation
(if applicable)
Sfmt 4703
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Laura R. Epstein, Center for Veterinary
Medicine (HFV–1), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 301–796–8558,
laura.epstein@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 19, 2017,
FDA published a notice announcing the
availability of draft GFI #187 entitled
‘‘Regulation of Intentionally Altered
Genomic DNA in Animals’’ with a 90day comment period. We requested
comments on expanding the scope of
the guidance to address animals
intentionally altered through use of
genome editing techniques,
nomenclature, and on whether certain
E:\FR\FM\13APN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 70 (Thursday, April 13, 2017)]
[Notices]
[Pages 17841-17844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07468]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1610]
Medical Devices; Exemptions From Premarket Notification: Class I
Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
identified a list of class I devices that are now exempt from premarket
notification requirements, subject to certain limitations. FDA is
publishing this notice of that determination in accordance with
procedures established by the 21st Century Cures Act. This notice
represents FDA's final determination with respect to the class I
devices included in this document. FDA's action will decrease
regulatory burdens on the medical device industry and will eliminate
private costs and expenditures required to comply with certain Federal
regulation.
FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, email:
Gregory.Bennett@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 513 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. Under the
Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295),
and the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are
classified into class I (general controls) if there is information
showing that the general controls of the FD&C Act are sufficient to
assure safety and effectiveness; into class II (special controls), if
general controls, by themselves, are insufficient to provide reasonable
assurance of safety and effectiveness, but there is sufficient
information to establish special controls to provide such assurance;
and into class III (premarket approval), if there is insufficient
information to support classifying a device into class I or class II
and the device is a life sustaining or life supporting device, or is
for a use which is of substantial importance in preventing impairment
of human health, or presents a potential unreasonable risk of illness
or injury.
Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section
[[Page 17842]]
513(c) and (d) of the FD&C Act through the issuance of classification
regulations into one of these three regulatory classes. Devices
introduced into interstate commerce for the first time on or after May
28, 1976 (generally referred to as postamendments devices), are
classified through the premarket notification process under section
510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C
Act and the implementing regulations, part 807 of Title 21 of the Code
of Federal Regulations (CFR), require persons who intend to market a
new device to submit a premarket notification (510(k)) containing
information that allows FDA to determine whether the new device is
``substantially equivalent'' within the meaning of section 513(i) of
the FD&C Act to a legally marketed device that does not require
premarket approval.
The 21st Century Cures Act (Pub. L. 114-255) was signed into law on
December 13, 2016. Section 3054 of that Act amended section 510(l) of
the FD&C Act. As amended, section 510(l)(2) of the FD&C Act requires
FDA to identify through publication in the Federal Register, any type
of class I device that the Agency determines no longer requires a
report under section 510(k) of the FD&C Act to provide reasonable
assurance of safety and effectiveness. FDA is required to publish this
determination within 120 days of the date of enactment of the 21st
Century Cures Act and at least once every 5 years thereafter, as FDA
determines appropriate. Section 510(l)(2) further provides that upon
the date of publication of the Agency's determination in the Federal
Register, a 510(k) will no longer be required for these devices and the
classification regulation applicable to each such type of device shall
be deemed amended to incorporate such exemption. In a final action, FDA
intends to amend the codified language for each listed classification
regulation to reflect the final determination with respect to 510(k)
exemption. FDA's action will decrease regulatory burdens on the medical
device industry and will eliminate private costs and expenditures
required to comply with certain Federal regulation. Specifically,
regulated industry will no longer have to invest time and resources in
510(k) submissions for certain class I devices, including preparation
of documents and data for submission to FDA, payment of user fees
associated with 510(k) submissions, and responding to questions and
requests for additional information from FDA during 510(k) review.
II. Criteria for Exemption
As stated previously, section 3054 of the 21st Century Cures Act
amended section 510(l) of the FD&C Act. In doing so, the amendments
reorganized section 510(l) into subsections 510(l)(1) and (2). As such,
subsection 510(l)(1) provides that a class I device is exempt from the
premarket notification requirements under section 510(k) of the FD&C
Act, unless the device is intended for a use which is of substantial
importance in preventing impairment of human health or it presents a
potential unreasonable risk of illness or injury (hereafter ``reserved
criteria''). Based on these reserved criteria, FDA has evaluated all
class I devices to determine which device types should be exempt from
premarket notification requirements. In developing the list of exempt
devices, the Agency considered its experience in reviewing premarket
notifications for these devices, focusing on the risk inherent with the
device and the disease being treated or diagnosed (e.g., devices with
rapidly evolving technology or expansions of intended uses). The Agency
also considered the history of adverse event reports under the medical
device reporting program for these devices, as well as their history of
product recalls. Following these considerations, FDA reached the final
determination that the devices listed in table 1 do not meet the
reserved criteria in that they are not intended for a use that is of
substantial importance in preventing impairment of human health or
present a potential unreasonable risk of illness or injury.
III. Limitations on Exemptions
FDA believes that the types of class I devices listed in this
notice should be exempt from the premarket notification requirements
found under section 510(k) of the FD&C Act. However, an exemption from
the requirement of premarket notification does not mean that the device
is exempt from any other statutory or regulatory requirements, unless
such exemption is explicitly provided by order or regulation. FDA's
determination that premarket notification is unnecessary to provide a
reasonable assurance of safety and effectiveness for devices listed in
this document is based, in part, on the assurance of safety and
effectiveness that other regulatory controls, such as current good
manufacturing practice requirements, provide.
In addition to being subject to the general limitations to the
exemptions found in 21 CFR 862.9, 864.9, 866.9, 872.9, 876.9, 878.9,
880.9, 882.9, 884.9 and 886.9, FDA may also partially limit the
exemption from premarket notification requirements to specific devices
within a listed device type. In table 1, for example, FDA lists the
exemption of the ataxiagraph device as 510(k) exempt, but limits the
exemption to such devices that do not provide an interpretation or a
clinical implication of the measurement. All other ataxiagraph devices
are still subject to premarket notification requirements because FDA
determined that premarket notification is necessary to provide a
reasonable assurance of safety and effectiveness for these devices.
IV. List of Class I Devices
FDA is identifying the following list of class I devices that no
longer require premarket notification under section 510(k) of the FD&C
Act, subject to the general limitations to the exemptions:
Table 1--Class I Devices
------------------------------------------------------------------------
Partial
Product exemption
21 CFR section Device type code limitation (if
applicable)
------------------------------------------------------------------------
862.1410.............. Bathophenanthroli CFM ................
ne, Colorimetry,
Iron (Non-Heme).
862.1410.............. Photometric JIY ................
Method, Iron
(Non-Heme).
862.1410.............. Atomic JIZ ................
Absorption, Iron
(Non-Heme).
862.1410.............. Radio-Labeled JJA ................
Iron Method,
Iron (Non-Heme).
862.1415.............. Ferrozine JMO ................
(Colorimetric)
Iron Binding
Capacity.
862.1415.............. Resin, Ion- JQD ................
Exchange,
Thioglycolic
Acid,
Colorimetry,
Iron Binding
Capacity.
862.1415.............. Resin, Ion- JQE ................
Exchange,
Ascorbic Acid,
Colorimetry,
Iron Binding
Capacity.
862.1415.............. Bathophenanthroli JQF ................
ne, Iron Binding
Capacity.
862.1415.............. Radiometric, JQG ................
Fe59, Iron
Binding Capacity.
[[Page 17843]]
862.1580.............. Phosphomolybdate CEO ................
(Colorimetric),
Inorganic
Phosphorus.
862.1660.............. Electrolyte JJR ................
Controls
(Assayed and
Unassayed).
862.1660.............. Controls For JJS ................
Blood-Gases,
(Assayed and
Unassayed).
862.1660.............. Enzyme Controls JJT ................
(Assayed and
Unassayed).
862.1660.............. Urinalysis JJW ................
Controls
(Assayed and
Unassayed).
862.1660.............. Single JJX Exemption is
(Specified) limited to
Analyte Controls controls not
(Assayed and intended for
Unassayed). use in donor
screening
tests.
862.1660.............. Multi-Analyte JJY Exemption is
Controls, All limited to
Kinds (Assayed). controls not
intended for
use in donor
screening
tests.
862.1660.............. Tonometer LCH ................
(Calibration and
Q.C. of Blood-
Gas
Instruments),
Clinical.
862.1660.............. Kit, Serological, MJX Exemption is
Positive Control. limited to
controls not
intended for
use in donor
screening
tests.
862.1660.............. Kit, Serological, MJY Exemption is
Negative Control. limited to
controls not
intended for
use in donor
screening
tests.
862.1660.............. Kit, Direct MJZ Exemption is
Antigen, limited to
Positive Control. controls not
intended for
use in donor
screening
tests.
862.1660.............. Kit, Direct MKA Exemption is
Antigen, limited to
Negative Control. controls not
intended for
use in donor
screening
tests.
862.1775.............. Acid, Uric, CDH ................
Phosphotungstate
Reduction.
862.1775.............. Acid, Uric, CDO ................
Uricase (U.V.).
862.1775.............. Acid, Uric, JHA ................
Uricase
(Gasometric).
862.1775.............. Acid, Uric, JHC ................
Uricase (Oxygen
Rate).
862.1775.............. Acid, Uric, Acid LFQ ................
Reduction of
Ferric Ion.
862.3050.............. Devices, Breath DJZ ................
Trapping,
Alcohol.
862.3220.............. Spectral Absorb. JKS ................
Curve,
Oxyhemoglobin,
Carboxyhemoglobi
n, Carbon-
Monoxide.
862.3220.............. Gas JKT ................
Chromatograph,
Carbon-Monoxide.
862.3220.............. Enzyme MKU ................
Immunoassasy,
Nocotine and
Nicotine
Metabolites.
862.3240.............. Cholinesterase DIG ................
Test Paper.
862.3240.............. Colorimetry, DIH ................
Cholinesterase.
862.3240.............. Acetylcholine DLI ................
Chloride,
Specific Reagent
for Pseudo
Cholinesterase.
862.3240.............. Solution, M- DMR ................
Nitrophenol,
Specific Reagent
for
Cholinesterase.
862.3240.............. Electrometry, DOH ................
Cholinesterase.
862.3280.............. Heavy Metals DIE ................
Control
Materials.
862.3280.............. Drug Mixture DIF ................
Control
Materials.
862.3280.............. Digitoxin Control DJK ................
Serum, Ria.
862.3280.............. Alcohol Control DKC ................
Materials.
862.3280.............. Digoxin Control DMP ................
Serum, Ria.
862.3280.............. Drug Specific LAS ................
Control
Materials.
862.3280.............. Theophylline LAW ................
Control
Materials.
862.3280.............. Lidocaine Control LAX ................
Materials.
862.3280.............. Methotrexate LAY ................
Control
Materials.
862.3280.............. N- LAZ ................
Acetylprocainami
de Control
Materials.
862.3280.............. Procainamide LBA ................
Control
Materials.
864.7040.............. ATP Release JWR ................
(Luminescence).
864.7040.............. Adenine KHF ................
Nucleotide
Quantitation.
866.2900.............. Device, Parasite LKS ................
Concentration.
872.4565.............. Parallelometer... EGI ................
872.4565.............. Syringe, EIB ................
Irrigating
(Dental).
876.5160.............. External Urethral MNG ................
Occluder,
Urinary
Incontinence-
Control, Female.
878.4014.............. Kit, First Aid, OVR ................
Talking.
880.5680.............. Pediatric PRN ................
Position Holder.
880.6250.............. Finger Cot....... LZB ................
880.6320.............. Device, Medical KZF ................
Examination, AC
Powered.
880.6320.............. Accessories to PEQ ................
Examination
Light.
880.6375.............. Lubricant, KMJ ................
Patient.
880.6760.............. Restraint, BRT ................
Patient,
Conductive.
880.6760.............. Restraint, FMQ ................
Protective.
880.6760.............. Patient Bed with OYS ................
Canopy/
Restraints.
882.1030.............. Ataxiagraph...... GWW Exemption is
limited to
ataxiagraph
devices not
intended to
provide an
interpretation
or a clinical
implication of
the
measurement.
882.4060.............. Cannula, HCD ................
Ventricular.
882.4545.............. Instrument, Shunt GYK ................
System
Implantation.
884.5435.............. Pad, Menstrual, NUQ ................
Reusable.
884.5435.............. Pad, Interlabial. NUR ................
[[Page 17844]]
886.4070.............. Engine, Trephine, HLD ................
Accessories, Gas-
powered.
886.4070.............. Burr, Corneal, HOG ................
Battery-powered.
886.4070.............. Engine, Trephine, HRF ................
Accessories,
Battery-powered.
886.4070.............. Engine, Trephine, HRG ................
Accessories, AC-
powered.
886.4070.............. Burr, Corneal, AC- HQS ................
powered.
------------------------------------------------------------------------
Dated: April 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-07468 Filed 4-12-17; 8:45 am]
BILLING CODE 4164-01-P
