[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Rules and Regulations]
[Pages 70112-70114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28873]
[[Page 70112]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2010-N-0513]
Medical Devices; General and Plastic Surgery Devices;
Classification of Non-Powered Suction Apparatus Device Intended for
Negative Pressure Wound Therapy
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the non-
powered suction apparatus device intended for negative pressure wound
therapy (NPWT) into class II (special controls). The special control
that will apply to the device is the guidance document entitled ``Class
II Special Controls Guidance Document: Non-Powered Suction Apparatus
Device Intended for Negative Pressure Wound Therapy.'' The agency is
classifying the device into class II (special controls) in order to
provide a reasonable assurance of safety and effectiveness of the
device. Elsewhere in this issue of the Federal Register, FDA is
publishing a notice of availability for the guidance document entitled
``Class II Special Controls Guidance Document: Non-Powered Suction
Apparatus Device Intended for Negative Pressure Wound Therapy.''
DATES: Effective Date: December 17, 2010.
FOR FURTHER INFORMATION CONTACT: Jiyoung Dang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3615, Silver Spring, MD 20993, 301-796-5650.
SUPPLEMENTARY INFORMATION:
I. What is the background of this rulemaking?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990
(the SMDA) (Public Law 101-629), and the Food and Drug Administration
Modernization Act (the FDAMA) (Public Law 107-250) 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
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
FDA refers to devices that were not in commercial distribution
prior to May 28, 1976 (the date of enactment of the 1976 amendments),
as postamendments devices. Postamendments devices are classified
automatically by statute (section 513(f) of the FD&C Act) into class
III without any FDA rulemaking process. These devices remain in class
III and require premarket approval, unless: (1) FDA reclassifies the
device into class I or II; (2) FDA issues an order classifying the
device into class I or class II in accordance with section 513(f)(2);
or FDA issues an order finding the device to be substantially
equivalent, under section 513(i) of the FD&C Act), 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).
Section 513(f)(2) of the FD&C Act provides that any person who
submits a premarket notification under section 510(k) of the FD&C Act
for a device that has not previously been classified may, within 30
days after receiving an order classifying the device into class III
under section 513(f)(1) of the FD&C Act, request that FDA classify the
device under the criteria set forth in section 513(a)(1) of the FD&C
Act. FDA will, within 60 days of receiving this request, classify the
device by written order. This classification shall be the initial
classification of the device. Within 30 days after the issuance of an
order classifying the device, FDA must publish a notice in the Federal
Register announcing this classification.
In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on October 28, 2008, classifying the SNaP Wound Care Device into
class III, because it was not substantially equivalent to a device that
was introduced or delivered for introduction into interstate commerce
for commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II. On November 3,
2008, Spiracur, Inc., submitted a petition requesting classification of
the SNaP Wound Care Device under section 513(f)(2) of the FD&C Act. The
manufacturer recommended that the device be classified into class II
(Ref. 1).
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the petition in order to classify the device under the criteria for
classification set forth in 513(a)(1) of the FD&C Act. FDA classifies
devices into class II 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 reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the petition, FDA determined that the device
can be classified into class II with the establishment of special
controls. FDA believes these special controls will provide reasonable
assurance of the safety and effectiveness of the device.
The device is assigned the generic name SNaP Wound Care Device, and
it is identified as non-powered suction apparatus device intended for
negative pressure wound therapy.
FDA has identified the following risks to health associated
specifically with this type of device and the recommended measures to
mitigate these risks.
Adverse tissue reaction
Material degradation
Improper function of suction apparatus (e.g., reflux of
waste exudate to wound, incorrect delivery of negative pressure)
Non-compatibility with other therapeutics and diagnostics
(e.g., MRI, hyperbaric chamber, defibrillation)
Uncontrolled bleeding
Transmission of infectious agents
Unsafe use of device (e.g., improper wound selection,
improper wound management, improper placement of dressing)
Table 1--Risks to Health and Mitigation Measures
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Identified risk Recommended mitigation measures
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Adverse tissue reaction..................... Section 6. Biocompatibility.
Section 7. Sterility.
Material degradation........................ Section 8. Stability and Shelf Life.
[[Page 70113]]
Improper function of suction apparatus Section 9. Performance Testing.
(e.g., reflux of waste exudate to wound,
incorrect delivery of negative pressure).
Non-compatibility with other therapeutics Section 9. Performance Testing.
and diagnostics (e.g., MRI, hyperbaric Section 11. Labeling.
chamber, defibrillation).
Uncontrolled bleeding....................... Section 11. Labeling.
Transmission of infectious agents........... Section 11. Labeling.
Unsafe use of device (e.g., improper wound Section 11. Labeling.
selection, improper wound management,
improper placement of dressing).
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FDA believes that the special controls guidance document, in
addition to general controls, address the risks to health identified in
table 1 of this document and provides reasonable assurance of the
safety and effectiveness of the device. Therefore, on August 7, 2009,
FDA issued an order to the petitioner classifying the device into class
II. FDA is codifying this device by adding 21 CFR 878.4683.
Following the effective date of the final classification rule, any
firm submitting a 510(k) premarket notification for a non-powered
suction apparatus device intended for negative pressure wound therapy
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 assurance of safety and effectiveness.
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirement 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. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device and,
therefore, the type of device is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the non-powered suction apparatus
device intended for negative presure wound therapy they intend to
market.
II. What is the environmental impact of this rule?
The agency has determined under 21 CFR 25.34(b) that this 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.
III. What is the economic impact of this rule?
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 as defined by
the Executive order and so it is not subject to review under 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 reclassification of this device from class
III to class II will relieve manufacturers of the device of the cost of
complying with the premarket approval requirements of section 515 of
the FD&C Act (21 U.S.C. 360e), and may permit small potential
competitors to enter the marketplace by lowering their costs, 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.
IV. Does this final rule have federalism implications?
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
authority 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. 21
U.S.C. 360k; See Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v.
Medtronic, 552 U.S. 312 (2008). The special controls established by
this final rule create ``requirements'' to address each identified risk
to health presented by these specific medical devices under 21 U.S.C.
360k, even though product sponsors have some flexibility in how they
meet those requirements. Cf. Papike v. Tambrands, Inc., 107 F.3d 737,
740-42 (9th Cir. 1997).
V. How does this rule comply with the Paperwork Reduction Act of 1995?
This final rule contains no new collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 is not required. Elsewhere in this
issue of the Federal Register, FDA is issuing a notice announcing the
guidance for the final rule. This guidance, ``Class II Special Controls
Guidance Document: Non-powered Suction Apparatus Device Intended for
Negative Pressure Wound Therapy,'' references previously approved
collections of information found in FDA regulations.
[[Page 70114]]
VI. What references are on display?
The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Petition from Spiracur, Inc., November 3, 2008.
List of Subjects in 21 CFR Part 878
Medical devices.
0
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 878.4683 is added to subpart E to read as follows:
Sec. 878.4683 Non-Powered suction apparatus device intended for
negative pressure wound therapy.
(a) Identification. A non-powered suction apparatus device intended
for negative pressure wound therapy is a device that is indicated for
wound management via application of negative pressure to the wound for
removal of fluids, including wound exudate, irrigation fluids, and
infectious materials. It is further indicated for management of wounds,
burns, flaps, and grafts.
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: Non-powered Suction Apparatus Device Intended for Negative
Pressure Wound Therapy (NPWT).'' See Sec. 878.1(e) for the
availability of this guidance document.
Dated: November 10, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-28873 Filed 11-16-10; 8:45 am]
BILLING CODE 4160-01-P