[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Rules and Regulations]
[Pages 22805-22807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9899]
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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.
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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
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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
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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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