[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Rules and Regulations]
[Pages 53165-53167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24963]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2009-N-0333]


Medical Devices; Plastic Surgery Devices; Classification of Wound 
Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) Additive

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
wound dressing with pDADMAC additive into class II (special controls). 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of a guidance document entitled ``Class II Special 
Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl 
Ammonium Chloride) (pDADMAC) Additive,'' which will serve as the 
special control for this device type. The agency is classifying this 
device type into class II (special controls) in order to provide a 
reasonable assurance of safety and effectiveness of these devices.

DATES: This final rule is effective November 16, 2009.

FOR FURTHER INFORMATION CONTACT: Sam Arepalli, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 3612, Silver Spring, MD 20993, 301-796-
6434.

SUPPLEMENTARY INFORMATION:

I. What Is the Background of This Rulemaking?

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in 
commercial distribution before May 28, 1976, the date of enactment of 
the Medical Device Amendments of 1976 (the amendments), generally 
referred to as postamendments devices, are classified automatically by 
statute into class III without any FDA rulemaking process. These 
devices remain in class III and require premarket approval, unless the 
device is classified or reclassified into class I or class II, or FDA 
issues an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the act, to a predicate device that 
does not require premarket approval. The agency determines whether new 
devices are substantially

[[Page 53166]]

equivalent to predicate devices by means of premarket notification 
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 
of FDA's regulations (21 CFR part 807).
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act for a device 
that has not previously been classified may, within 30 days after 
receiving an order classifying the device in class III under section 
513(f)(1) of the act, request FDA to classify the device under the 
criteria set forth in section 513(a)(1) of the act. FDA shall, within 
60 days of receiving such a request, classify the device by written 
order. This classification shall be the initial classification of the 
device type. Within 30 days after the issuance of an order classifying 
the device, FDA must publish a notice in the Federal Register 
announcing such classification (section 513(f)(2) of the act).
    In accordance with section 513(f)(1) of the act, FDA issued a 
written notice of classification on June 23, 2006, classifying the QMT 
NIMBUS Barrier Gauze Dressing intended for use as a primary dressing 
for exuding wounds, 1st and 2d degree burns, and surgical wounds, to 
secure and prevent movement of a primary dressing, and as a wound 
packing in 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 that was subsequently reclassified into class I or class II. 
On May 10, 2007, Quick-Med Technologies, Inc., submitted a petition 
requesting classification of the QMT NIMBUS Barrier Gauze Dressing 
intended for use as a primary dressing for exuding wounds, 1st and 2d 
degree burns, and surgical wounds, to secure and prevent movement of a 
primary dressing, and as a wound packing under section 513(f)(2) of the 
act. The manufacturer recommended that the device be classified into 
class II (Ref. 1).
    In accordance with section 513(f)(2) of the act, FDA reviewed the 
petition in order to classify the device under the criteria for 
classification set forth in 513(a)(1) of the act. Devices are to be 
classified 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 wound 
dressing with pDADMAC additive can be classified into class II with the 
establishment of special controls. FDA believes that these special 
controls, in addition to general controls, are adequate to provide 
reasonable assurance of the safety and effectiveness of the device. The 
device is assigned the generic name ``Wound Dressing with pDADMAC 
Additive.'' A wound dressing with pDADMAC additive is a medical device 
that is used as a primary dressing for exuding wounds, 1st and 2d 
degree burns, and surgical wounds, to secure and prevent movement of a 
primary dressing, and as a wound packing.
    FDA has identified the following risks to health associated with 
this type of device as:
    1. Infection,
    2. Adverse tissue reactions,
    3. Leaching (of the pDADMAC into the wound),
    4. Degradation (of materials leading to device failure), and
    5. Necrosis and pain.
    FDA believes that the class II special controls guidance document 
will aid in mitigating the potential risks to health as described in 
Table 1 of this document.

            Table 1.--Risks to Health and Mitigation Measures
------------------------------------------------------------------------
          Identified Risk              Recommended Mitigation Measures
------------------------------------------------------------------------
Infection                            Sterility
                                     Biochemical testing
------------------------------------------------------------------------
Adverse tissue reaction              Biocompatibility
------------------------------------------------------------------------
Leaching (of the additive pDADMAC    Non-leachability
 into the wound)
------------------------------------------------------------------------
Degradation (of materials leading    Shelf life testing
 to device failure)
------------------------------------------------------------------------
Necrosis or pain                     Labeling
------------------------------------------------------------------------

    FDA believes that the special controls, in addition to general 
controls, address the risks to health identified previously and provide 
reasonable assurances of the safety and effectiveness of the device 
type. Thus, on February 25, 2009, FDA issued an order to the petitioner 
classifying the device into class II. FDA is codifying this 
classification at 21 CFR 878.4015.
    Following the effective date of the final classification rule, 
manufacturers will need to address the issues covered in the special 
controls guidance. However, the manufacturer 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 act provides that FDA may exempt a class II 
device from the premarket notification requirement under section 510(k) 
of the act, if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. There is no such exemption for this type 
of device. 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 wound dressing with pDADMAC additive 
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. Thus, 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, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies

[[Page 53167]]

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 classification of this device into class II 
will relieve manufacturers of the cost of complying with the premarket 
approval requirements of section 515 of the 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 $133 
million, using the most current (2008) 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; Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v. 
Medtronic, 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 (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 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: Wound Dressing With Poly (Diallyl Dimethyl Ammonium 
Chloride) (pDADMAC) Additive,'' references previously approved 
collections of information found in FDA regulations.

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 Quick-Med Technologies, Inc., May 10, 2007.

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 878.4015 is added to subpart E to read as follows:


Sec.  878.4015  Wound dressing with poly (diallyl dimethyl ammonium 
chloride) (pDADMAC) additive.

    (a) Identification. A wound dressing with pDADMAC additive is 
intended for use as a primary dressing for exuding wounds, 1st and 2d 
degree burns, and surgical wounds, to secure and prevent movement of a 
primary dressing, and as a wound packing.
    (b) Classification. Class II (special controls). The special 
control is: the FDA guidance document entitled ``Class II Special 
Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl 
Ammonium Chloride) (pDADMAC) Additive.'' See Sec.  878.1(e) for 
availability of this guidance document.

    Dated: October 2, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-24963 Filed 10-15-09; 8:45 am]
BILLING CODE 4160-01-S