[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.
    <bullet> Adverse tissue reaction
    <bullet> Material degradation
    <bullet> Improper function of suction apparatus (e.g., reflux of 
waste exudate to wound, incorrect delivery of negative pressure)
    <bullet> Non-compatibility with other therapeutics and diagnostics 
(e.g., MRI, hyperbaric chamber, defibrillation)
    <bullet> Uncontrolled bleeding
    <bullet> Transmission of infectious agents
    <bullet> 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.

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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).
----------------------------------------------------------------------------------------------------------------

    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.

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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