Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities, 22805-22807 [2011-9899]
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Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Rules and Regulations
inspections and examinations in
connection with preclearing passengers,
crew, and their goods bound for the
United States. Generally, travelers who
are inspected at a preclearance facility
are permitted to arrive at a U.S.
domestic facility and exit the U.S.
domestic terminal upon arrival or
connect directly to a U.S. domestic
flight without further CBP processing.
Preclearance facilities primarily serve to
facilitate low risk travelers, relieve
passenger congestion at federal
inspection facilities in the United
States, and enhance security in the air
environment through the screening and
inspection of travelers prior to their
arrival in the United States. In Fiscal
Year 2010, over 14 million aircraft
travelers were processed at preclearance
locations. This figure represents more
than 16 percent of all commercial
aircraft travelers cleared by CBP in FY
2010.
The Agreement Between the
Government of the United States of
America and the Government of Ireland
on Air Transport Preclearance was
signed on November 17, 2008.
Preclearance operations began in
Dublin, Ireland on January 19, 2011.
The Dublin preclearance station is open
for use by commercial flights.
Section 101.5 of the CBP regulations
(19 CFR 101.5) sets forth a list of CBP
preclearance offices in foreign countries.
This document amends this section to
add Dublin, Ireland to the list of
preclearance offices.
Inapplicability of Public Notice and
Delayed Effective Date Requirements
This amendment reflects the addition
of a new CBP preclearance office that
was established through a signed
agreement between the United States
and the Government of Ireland.
Accordingly, pursuant to 5 U.S.C.
553(b)(B), notice and public procedure
are unnecessary. For the same reason,
pursuant to 5 U.S.C. 553(d)(3), a delayed
effective date is not required.
List of Subjects in 19 CFR Part 101
Customs duties and inspection,
Customs ports of entry, Foreign trade
statistics, Imports, Organization and
functions (Government agencies),
Shipments, Vessels.
Amendments to Regulations
For the reasons set forth above, Part
101 of the Code of Federal Regulations
(19 CFR part 101), is amended as set
forth below.
PART 101—GENERAL PROVISIONS
1. The general authority citation for
part 101 and the specific authority
citation for section 101.5 continue to
read as follows:
■
Authority: 5 U.S.C. 301; 19 U.S.C. 2, 66,
1202 (General Note 3(i), Harmonized Tariff
Schedule of the United States), 1623, 1624,
1646a.
*
*
*
*
■
*
*
*
*
*
2. Revise § 101.5 to read as follows:
§ 101.5 CBP preclearance offices in
foreign countries.
Listed below are the preclearance
offices in foreign countries where CBP
officers are located. A Director,
Preclearance, located in the Office of
Field Operations at CBP Headquarters,
is the responsible CBP officer exercising
supervisory control over all
preclearance offices.
Country
CBP office
Aruba ............
The Bahamas
Orangestad.
Freeport.
Nassau.
Kindley Field.
Calgary, Alberta.
Edmonton, Alberta.
Halifax, Nova Scotia.
Montreal, Quebec.
Ottawa, Ontario.
Toronto, Ontario.
Vancouver, British Columbia.
Winnipeg, Manitoba.
Dublin.
Shannon.
Bermuda .......
Canada .........
The Regulatory Flexibility Act and
Executive Order 12866
jdjones on DSKHWCL6B1PROD with RULES
*
Section 101.5 also issued under 19 U.S.C.
1629.
Ireland ..........
Because no notice of proposed
rulemaking is required, the provisions
of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.) do not apply. This
amendment does not meet the criteria
for a ‘‘significant regulatory action’’ as
specified in Executive Order 12866.
Dated: February 11, 2011.
Alan D. Bersin,
Commissioner, U.S. Customs and Border
Protection.
Signing Authority
[FR Doc. 2011–9883 Filed 4–22–11; 8:45 am]
This document is being issued in
accordance with 19 CFR 0.2(a).
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22805
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA–2006–N–0045] (Formerly
Docket No. 2006N–0109)
Medical Devices; Reclassification of
the Topical Oxygen Chamber for
Extremities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is reclassifying
the topical oxygen chamber for
extremities (TOCE) from class III to class
II. This device is intended to surround
a patient’s limb and apply humidified
oxygen topically at a pressure slightly
greater than atmospheric pressure to aid
healing of chronic skin ulcers, such as
bedsores. This reclassification is on the
Secretary of Health and Human
Services’s own initiative based on new
information. This action is being taken
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) as
amended by the Medical Device
Amendments of 1976 (the 1976
Amendments), the Safe Medical Devices
Act of 1990 (the SMDA), and the Food
and Drug Administration Modernization
Act of 1997 (FDAMA). Elsewhere in this
issue of the Federal Register, FDA is
announcing the availability of the
guidance document entitled ‘‘Class II
Special Controls Guidance Document:
Topical Oxygen Chamber for
Extremities,’’ which will serve as the
special control for this device.
DATES: This rule is effective May 25,
2011.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Charles N. Durfor, Center for Devices
and Radiological Health (HFZ–410),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3555.
SUPPLEMENTARY INFORMATION:
I. Background
The FD&C Act (21 U.S.C. 301 et seq.),
as amended by the 1976 Amendments
(Pub. L. 94–295), the SMDA (Pub. L.
101–629), and the FDAMA (Pub. L. 105–
115), established a comprehensive
system for the regulation of medical
devices intended for human use.
Section 513 of the FD&C Act (21 U.S.C.
360c) established three categories
(classes) of devices, depending on the
regulatory controls needed to provide
reasonable assurance of their safety and
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22806
Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Rules and Regulations
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Under section 513 of the FD&C Act,
devices that were in commercial
distribution before May 28, 1976 (the
date of enactment of the 1976
Amendments), generally referred to as
preamendments devices, are classified
after FDA has: (1) Received a
recommendation from a device
classification panel (an FDA advisory
committee); (2) published the panel’s
recommendation for comment, along
with a proposed regulation classifying
the device; and (3) published a final
regulation classifying the device. FDA
has classified most preamendments
devices under these procedures.
Devices that were not in commercial
distribution prior to May 28, 1976,
generally referred to as postamendments
devices, are classified automatically by
statute (section 513(f) of the FD&C Act
(21 U.S.C. 360c(f)) into class III without
any FDA rulemaking process.
Postamendment devices remain in class
III and require premarket approval,
unless the device is reclassified into
class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act (21 U.S.C.
360c(i)), to a predicate device that does
not require premarket approval. The
agency determines whether new devices
are substantially equivalent to predicate
devices by means of premarket
notification procedures in section 510(k)
of the FD&C Act (21 U.S.C. 360(k)) and
part 807 of the regulations (21 CFR part
807).
A preamendments device that has
been classified into class III may be
marketed, by means of premarket
notification procedures, without
submission of a premarket approval
application (PMA) until FDA issues a
final regulation under section 515(b) of
the FD&C Act (21 U.S.C. 360e(b))
requiring premarket approval.
Section 513(e) of the FD&C Act (21
U.S.C. 360c(e)) governs reclassification
of classified preamendments devices.
This section provides that FDA may, by
rulemaking, reclassify a device based
upon ‘‘new information.’’ FDA can
initiate a reclassification under section
513(e) of the FD&C Act or an interested
person may petition FDA to reclassify a
preamendments device. The term ‘‘new
information,’’ as used in section 513(e)
of the FD&C Act, includes information
developed as a result of a reevaluation
of the data before the agency when the
device was originally classified, as well
as information not presented, not
available, or not developed at that time.
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(See, e.g., Holland Rantos v. United
States Department of Health, Education,
and Welfare, 587 F.2d 1173, 1174 n.1
(DC Cir. 1978); Upjohn v. Finch, 422
F.2d 944 (6th Cir. 1970); Bell v.
Goddard, 366 F.2d 177 (7th Cir. 1966)).
Reevaluation of the data previously
before the agency is an appropriate basis
for subsequent regulatory action where
the reevaluation is made in light of
newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at
181; Ethicon, Inc. v. FDA, 762 F. Supp.
382, 389–91 (D.D.C. 1991)), or in light
of changes in ‘‘medical science.’’ (See
Upjohn v. Finch, supra, 422 F.2d at
951). Regardless of whether data before
the agency are past or new data, the
‘‘new information’’ to support
reclassification under section 513(e)(1)
of the FD&C Act must be ‘‘valid
scientific evidence,’’ as defined in
section 513(a)(3) of the FD&C Act
(21 U.S.C. 360c(a)(3)) and 21 CFR
860.7(c)(2). (See, e.g., General Medical
Co. v. FDA, 770 F.2d 214 (DC Cir. 1985);
Contact Lens Assoc. v. FDA, 766 F.2d
592 (DC Cir.), cert. denied, 474 U.S.
1062 (1985)). FDA relies upon ‘‘valid
scientific evidence’’ in the classification
process to determine the level of
regulation for devices. For the purpose
of reclassification, the valid scientific
evidence upon which the agency relies
must be publicly available. Publicly
available information excludes trade
secret and/or confidential commercial
information, e.g., the contents of a
pending PMA. (See section 520(c) of the
FD&C Act (21 U.S.C. 360j(c)).
In accordance with section 513(e) of
the FD&C Act and 21 CFR 860.130(b)(1),
based on new information with respect
to the device, FDA, on its own initiative,
is reclassifying this device from class III
to class II.
II. Regulatory History of the Device
As discussed in the proposed rule, the
agency issued a final rule classifying
this device into class III (53 FR 23856,
June 24, 1988). In August 1997, in
response to FDA’s order for the
submission of information on the TOCE,
two manufacturers submitted 515(i)
summaries of safety and effectiveness
information to the agency for the TOCE.
FDA referred the 515(i) submissions to
the General and Plastic Surgery Devices
Panel (GPS Panel) for their
recommendation on the requested
reclassification. At a public meeting on
November 17, 1998, the GPS Panel
recommended that the device be
retained in class III.
Since the 1998 GPS Panel meeting,
three studies (two prospective and one
retrospective) reported safe use and
adequate healing of wounds using the
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TOCE. In addition, FDA has evaluated
more than 20 years of clinical
experience with the device and the
agency’s Medical Device Reports, and
has found sufficient information to
determine the risks to health associated
with the use of this device and develop
appropriate special controls.
As a result, in the Federal Register of
April 6, 2006 (71 FR 17390), FDA
proposed to reclassify the TOCE device
from class III to class II. The device is
intended to surround a patient’s limb
and apply humidified oxygen topically
at a pressure slightly greater than
atmospheric pressure to aid healing of
chronic skin ulcers such as bedsores.
Elsewhere in the Federal Register of
April 6, 2006 (71 FR 17476), FDA
announced the availability of the draft
guidance document entitled ‘‘Class II
Special Controls Draft Guidance
Document: Topical Oxygen Chamber for
Extremities,’’ which FDA intended to
serve as the special control for this
device type following the effective date
of the final reclassification rule.
Interested persons were invited to
comment until July 5, 2006, on the
proposed regulation and special
controls draft guidance document.
III. Analysis of Comments and FDA’s
Response
FDA received 11 comments on the
proposed rule. The comments received
discussed academic literature, clinical
experiences, and patient outcomes that
support the proposed reclassification’s
determinations of the safety and
effectiveness of the TOCE device. The
comments did not recommend any
changes to the proposed regulation.
IV. Summary of Final Rule
Based on the information discussed in
the preamble to the proposed rule, the
comments on the proposed rule, a
review of the Manufacturer and User
Facility Device Experience (MAUDE)
database, and a review of current
scientific literature, FDA concludes that
special controls, in conjunction with
general controls, will provide
reasonable assurance of the safety and
effectiveness of TOCE. The agency is,
therefore, reclassifying TOCE from class
III (premarket approval) into class II
(special controls) and issuing a final
rule that revises 21 CFR 878.5650.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of the guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Topical Oxygen
Chamber for Extremities,’’ which will
serve as the special control for this
device. Following the effective date of
this final classification rule, any firm
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Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Rules and Regulations
submitting a 510(k) premarket
notification for a TOCE will need to
address the issues covered in the special
controls guidance. However, the firm
need only show that its device meets the
recommendations of the guidance or in
some other way provides equivalent
assurances of safety and effectiveness.
Section 510(m) of the FD&C Act
(21 U.S.C. 360(m)) provides that FDA
may exempt a class II device from the
premarket notification requirements
under section 510(k) of the FD&C Act if
FDA determines that premarket
notification is not necessary to provide
reasonable assurance of the safety and
effectiveness of the device. FDA has
determined that premarket notification
is necessary to provide reasonable
assurance of the safety and effectiveness
of the TOCE and, therefore, this device
type is not exempt from premarket
notification requirements.
jdjones on DSKHWCL6B1PROD with RULES
V. Environmental Impact
The agency has determined under
21 CFR 25.34(b) that this reclassification
action is of a type that does not
individually or cumulatively have a
significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
VI. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866
and the Regulatory Flexibility Act
(5 U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4). Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). The
agency believes that this final rule is not
a significant regulatory action under the
Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because the final rule
reclassifying this device from class III to
class II will relieve all manufacturers of
the device of the cost of complying with
the premarket approval requirements of
section 515 of the FD&C Act, it will
impose no significant economic impact
on any small entities, and it may permit
small potential competitors to enter the
marketplace by lowering their costs, and
the agency certifies that the final rule
will not have a significant economic
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impact on a substantial number of small
entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is
$135 million, using the most current
(2009) Implicit Price Deflator for the
Gross Domestic Product. FDA does not
expect this final rule to result in any
1-year expenditure that would meet or
exceed this amount.
VII. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. Section 4(a)
of the Executive order requires agencies
to ‘‘construe * * * a Federal statute to
preempt State law only where the
statute contains an express preemption
provision or there is some other clear
evidence that the Congress intended
preemption of State law, or where the
exercise of State law conflicts with the
exercise of Federal authority under the
Federal statute.’’ Federal law includes
an express preemption provision that
preempts certain State requirements
‘‘different from or in addition to’’ certain
Federal requirements applicable to
devices. (See section 521 of the FD&C
Act (21 U.S.C. 360k); Medtronic Inc., v.
Lohr, 518 U.S. 470 (1996); Riegel v.
Medtronic Inc., 128 S. Ct. 999 (2008)).
The special controls established by this
final rule create ‘‘requirements’’ for
specific medical devices under
21 U.S.C. 360k, even though product
sponsors have some flexibility in how
they meet those requirements. See
Papike v. Tambrands, Inc., 107 F.3d
737, 740–742 (9th Cir. 1997).
VIII. Paperwork Reduction Act of 1995
This final rule contains no collections
of information. Therefore, clearance by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3520) is not required. FDA concludes
that the special controls guidance
document identified by this rule
contains information collection
provisions that are subject to review and
clearance by OMB under the PRA.
Elsewhere in this issue of the Federal
Register, FDA is publishing a notice
announcing the availability of the
guidance document entitled, ‘‘Class II
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22807
Special Controls Guidance Document:
Topical Oxygen Chamber for
Extremities.’’ The notice contains an
analysis of the paperwork burden for the
guidance.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 878 is
amended as follows:
PART 878—GENERAL AND PLASTIC
SURGERY DEVICES
1. The authority citation for 21 CFR
part 878 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Section 878.5650 is revised to read
as follows:
■
§ 878.5650 Topical oxygen chamber for
extremities.
(a) Identification. A topical oxygen
chamber for extremities is a device that
is intended to surround a patient’s limb
and apply humidified oxygen topically
at a pressure slightly greater than
atmospheric pressure to aid healing of
chronic skin ulcers such as bedsores.
(b) Classification. Class II (special
controls). The special control for this
device is FDA’s ‘‘Class II Special
Controls Guidance: Topical Oxygen
Chamber for Extremities.’’ See § 878.1(e)
for the availability of this guidance
document.
Dated: April 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–9899 Filed 4–22–11; 8:45 am]
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DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DoD–2011–OS–0008]
32 CFR Part 321
Privacy Act of 1974; Implementation
Defense Security Service, DoD.
Direct final rule with request for
comments.
AGENCY:
ACTION:
The Defense Security Service
is deleting an exemption rule for V5–05
entitled ‘‘Joint Personnel Adjudication
System (JPAS)’’ in its entirety. The
system has been transferred to the Office
of the Secretary of Defense.
This direct final rule makes
nonsubstantive changes to the Defense
SUMMARY:
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]]>Agencies
[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Rules and Regulations]
[Pages 22805-22807]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9899]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2006-N-0045] (Formerly Docket No. 2006N-0109)
Medical Devices; Reclassification of the Topical Oxygen Chamber
for Extremities
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is reclassifying the
topical oxygen chamber for extremities (TOCE) from class III to class
II. This device is intended to surround a patient's limb and apply
humidified oxygen topically at a pressure slightly greater than
atmospheric pressure to aid healing of chronic skin ulcers, such as
bedsores. This reclassification is on the Secretary of Health and Human
Services's own initiative based on new information. This action is
being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) as amended by the Medical Device Amendments of 1976 (the 1976
Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the
Food and Drug Administration Modernization Act of 1997 (FDAMA).
Elsewhere in this issue of the Federal Register, FDA is announcing the
availability of the guidance document entitled ``Class II Special
Controls Guidance Document: Topical Oxygen Chamber for Extremities,''
which will serve as the special control for this device.
DATES: This rule is effective May 25, 2011.
FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3555.
SUPPLEMENTARY INFORMATION:
I. Background
The FD&C Act (21 U.S.C. 301 et seq.), as amended by the 1976
Amendments (Pub. L. 94-295), the SMDA (Pub. L. 101-629), and the FDAMA
(Pub. L. 105-115), established a comprehensive system for the
regulation of medical devices intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c) established three categories (classes) of
devices, depending on the regulatory controls needed to provide
reasonable assurance of their safety and
[[Page 22806]]
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
Under section 513 of the FD&C Act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
Amendments), generally referred to as preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the FD&C Act (21 U.S.C.
360c(f)) into class III without any FDA rulemaking process.
Postamendment devices remain in class III and require premarket
approval, unless the device is reclassified into class I or II, or FDA
issues an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act (21 U.S.C. 360c(i)), to
a predicate device that does not require premarket approval. The agency
determines whether new devices are substantially equivalent to
predicate devices by means of premarket notification procedures in
section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 of the
regulations (21 CFR part 807).
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the FD&C Act (21 U.S.C.
360e(b)) requiring premarket approval.
Section 513(e) of the FD&C Act (21 U.S.C. 360c(e)) governs
reclassification of classified preamendments devices. This section
provides that FDA may, by rulemaking, reclassify a device based upon
``new information.'' FDA can initiate a reclassification under section
513(e) of the FD&C Act or an interested person may petition FDA to
reclassify a preamendments device. The term ``new information,'' as
used in section 513(e) of the FD&C Act, includes information developed
as a result of a reevaluation of the data before the agency when the
device was originally classified, as well as information not presented,
not available, or not developed at that time. (See, e.g., Holland
Rantos v. United States Department of Health, Education, and Welfare,
587 F.2d 1173, 1174 n.1 (DC Cir. 1978); Upjohn v. Finch, 422 F.2d 944
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966)).
Reevaluation of the data previously before the agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762
F. Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in
``medical science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951).
Regardless of whether data before the agency are past or new data, the
``new information'' to support reclassification under section 513(e)(1)
of the FD&C Act must be ``valid scientific evidence,'' as defined in
section 513(a)(3) of the FD&C Act (21 U.S.C. 360c(a)(3)) and 21 CFR
860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (DC
Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (DC Cir.), cert.
denied, 474 U.S. 1062 (1985)). FDA relies upon ``valid scientific
evidence'' in the classification process to determine the level of
regulation for devices. For the purpose of reclassification, the valid
scientific evidence upon which the agency relies must be publicly
available. Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).
In accordance with section 513(e) of the FD&C Act and 21 CFR
860.130(b)(1), based on new information with respect to the device,
FDA, on its own initiative, is reclassifying this device from class III
to class II.
II. Regulatory History of the Device
As discussed in the proposed rule, the agency issued a final rule
classifying this device into class III (53 FR 23856, June 24, 1988). In
August 1997, in response to FDA's order for the submission of
information on the TOCE, two manufacturers submitted 515(i) summaries
of safety and effectiveness information to the agency for the TOCE. FDA
referred the 515(i) submissions to the General and Plastic Surgery
Devices Panel (GPS Panel) for their recommendation on the requested
reclassification. At a public meeting on November 17, 1998, the GPS
Panel recommended that the device be retained in class III.
Since the 1998 GPS Panel meeting, three studies (two prospective
and one retrospective) reported safe use and adequate healing of wounds
using the TOCE. In addition, FDA has evaluated more than 20 years of
clinical experience with the device and the agency's Medical Device
Reports, and has found sufficient information to determine the risks to
health associated with the use of this device and develop appropriate
special controls.
As a result, in the Federal Register of April 6, 2006 (71 FR
17390), FDA proposed to reclassify the TOCE device from class III to
class II. The device is intended to surround a patient's limb and apply
humidified oxygen topically at a pressure slightly greater than
atmospheric pressure to aid healing of chronic skin ulcers such as
bedsores. Elsewhere in the Federal Register of April 6, 2006 (71 FR
17476), FDA announced the availability of the draft guidance document
entitled ``Class II Special Controls Draft Guidance Document: Topical
Oxygen Chamber for Extremities,'' which FDA intended to serve as the
special control for this device type following the effective date of
the final reclassification rule.
Interested persons were invited to comment until July 5, 2006, on
the proposed regulation and special controls draft guidance document.
III. Analysis of Comments and FDA's Response
FDA received 11 comments on the proposed rule. The comments
received discussed academic literature, clinical experiences, and
patient outcomes that support the proposed reclassification's
determinations of the safety and effectiveness of the TOCE device. The
comments did not recommend any changes to the proposed regulation.
IV. Summary of Final Rule
Based on the information discussed in the preamble to the proposed
rule, the comments on the proposed rule, a review of the Manufacturer
and User Facility Device Experience (MAUDE) database, and a review of
current scientific literature, FDA concludes that special controls, in
conjunction with general controls, will provide reasonable assurance of
the safety and effectiveness of TOCE. The agency is, therefore,
reclassifying TOCE from class III (premarket approval) into class II
(special controls) and issuing a final rule that revises 21 CFR
878.5650. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of the guidance document entitled ``Class
II Special Controls Guidance Document: Topical Oxygen Chamber for
Extremities,'' which will serve as the special control for this device.
Following the effective date of this final classification rule, any
firm
[[Page 22807]]
submitting a 510(k) premarket notification for a TOCE will need to
address the issues covered in the special controls guidance. However,
the firm need only show that its device meets the recommendations of
the guidance or in some other way provides equivalent assurances of
safety and effectiveness.
Section 510(m) of the FD&C Act (21 U.S.C. 360(m)) provides that FDA
may exempt a class II device from the premarket notification
requirements under section 510(k) of the FD&C Act if FDA determines
that premarket notification is not necessary to provide reasonable
assurance of the safety and effectiveness of the device. FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the TOCE and,
therefore, this device type is not exempt from premarket notification
requirements.
V. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this
reclassification action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.
VI. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the final rule reclassifying this device
from class III to class II will relieve all manufacturers of the device
of the cost of complying with the premarket approval requirements of
section 515 of the FD&C Act, it will impose no significant economic
impact on any small entities, and it may permit small potential
competitors to enter the marketplace by lowering their costs, and the
agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
VII. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State law
conflicts with the exercise of Federal authority under the Federal
statute.'' Federal law includes an express preemption provision that
preempts certain State requirements ``different from or in addition
to'' certain Federal requirements applicable to devices. (See section
521 of the FD&C Act (21 U.S.C. 360k); Medtronic Inc., v. Lohr, 518 U.S.
470 (1996); Riegel v. Medtronic Inc., 128 S. Ct. 999 (2008)). The
special controls established by this final rule create ``requirements''
for specific medical devices under 21 U.S.C. 360k, even though product
sponsors have some flexibility in how they meet those requirements. See
Papike v. Tambrands, Inc., 107 F.3d 737, 740-742 (9th Cir. 1997).
VIII. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520) is not
required. FDA concludes that the special controls guidance document
identified by this rule contains information collection provisions that
are subject to review and clearance by OMB under the PRA.
Elsewhere in this issue of the Federal Register, FDA is publishing
a notice announcing the availability of the guidance document entitled,
``Class II Special Controls Guidance Document: Topical Oxygen Chamber
for Extremities.'' The notice contains an analysis of the paperwork
burden for the guidance.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Section 878.5650 is revised to read as follows:
Sec. 878.5650 Topical oxygen chamber for extremities.
(a) Identification. A topical oxygen chamber for extremities is a
device that is intended to surround a patient's limb and apply
humidified oxygen topically at a pressure slightly greater than
atmospheric pressure to aid healing of chronic skin ulcers such as
bedsores.
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance:
Topical Oxygen Chamber for Extremities.'' See Sec. 878.1(e) for the
availability of this guidance document.
Dated: April 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9899 Filed 4-22-11; 8:45 am]
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