[Federal Register Volume 65, Number 75 (Tuesday, April 18, 2000)]
[Rules and Regulations]
[Pages 20734-20735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. 94P-0347]


Medical Devices; Reclassification and Codification of the 
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
has issued an order in the form of a letter to W. L. Gore and 
Associates, Inc., reclassifying the nonabsorbable expanded 
polytetrafluoroethylene (ePTFE) surgical suture intended for use in 
soft tissue approximation and ligation, including cardiovascular 
surgery, from class III (premarket approval) to class II (special 
controls). Accordingly, the order is being codified in the Code of 
Federal Regulations (CFR).

EFFECTIVE DATES: The rule is effective May 18, 2000. The 
reclassification was effective September 9, 1999.

FOR FURTHER INFORMATION CONTACT: Anthony D. Watson, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3090.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

    The Federal Food, Drug, and Cosmetic Act (the 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 of 1997 (the FDAMA) (Public Law 105-115), established 
a comprehensive system for the regulation of medical devices intended 
for human use. Section 513 of the 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).
    The 1976 amendments broadened the definition of ``device'' in 
201(h) of the act (21 U.S.C. 321(h)) to include certain articles that 
were once regulated as drugs. Under the 1976 amendments, Congress 
classified all transitional devices, i.e., those devices previously 
regulated as new drugs, including the nonabsorbable ePTFE surgical 
suture, into class III. The legislative history of the SMDA reflects 
congressional concern that many transitional devices were being 
overregulated in class III (H. Rept. 808, 101st Cong., 2d sess. 26-27 
(1990); S. Rept. 513, 101st Cong., 2d sess. 27 (1990)). Congress 
amended section 520(l) of the act (21 U.S.C. 360j(l)) to direct FDA to 
collect certain safety and effectiveness information from the 
manufacturers of transitional devices still remaining in class III to 
determine whether the devices should be reclassified into class II 
(special controls) or class I (general controls). Accordingly, in the 
Federal Register Of November 14, 1991 (56 FR 57960), FDA issued an 
order under section 520(l)(5)(A) of the act, requiring manufacturers of 
transitional devices, including the nonabsorbable ePTFE surgical 
suture, to submit to FDA a summary of, and a citation to, any 
information known or otherwise available to them respecting the 
devices, including adverse safety or effectiveness information which 
had not been submitted under section 519 of the act (21 U.S.C. 360i). 
Manufacturers were to submit the summaries and citations to FDA by 
January 13, 1992. However, because of misunderstandings and 
uncertainties regarding the information required by the order, and 
whether the order applied to certain manufacturers' devices, many 
transitional class III device manufacturers failed to comply with the 
reporting requirement by January 13, 1992. Consequently, in the Federal 
Register of March 10, 1992 (57 FR 8462), FDA extended the reporting 
period to March 31, 1992.
    Section 520(l)(5)(B) of the act provides that, after the issuance 
of an order requiring manufacturers to submit a summary of, and 
citation to, any information known or otherwise available respecting 
the devices, but before December 1, 1992, FDA was to publish 
regulations either leaving transitional class III devices in class III 
or reclassifying them into class I or II. Subsequently, as permitted by 
section 520(l)(5)(C) of the act, in the Federal Register of November 
30, 1992 (57 FR 56586), the agency published a notice extending the 
period for issuing such regulations until December 1, 1993. Due to 
limited resources, FDA was unable to publish the regulations before the 
December 1, 1993, deadline.
    Nevertheless, in accordance with sections 520(l)(5)(B) and 513(a) 
of the act, FDA is now reclassifying the nonabsorbable ePTFE surgical 
suture from class III to class II.
    On September 14, 1994, FDA filed the reclassification petition 
submitted by W. L. Gore and Associates, Inc., requesting 
reclassification of the nonabsorbable ePTFE surgical suture from class 
III to class II.
    FDA consulted with members of the General and Plastic Surgery 
Devices Panel (the Panel) of the Medical Devices Advisory Committee 
about the requested reclassification. The Panel members recommended 
that the nonabsorbable ePTFE surgical suture intended for use in soft 
tissue approximation and ligation, including cardiovascular surgery, be 
reclassified from class III to class II. They also recommended FDA 
recognized consensus standards and device-specific labeling as the 
special controls for this device.
    After reviewing the data in the petition and considering the Panel 
members' recommendations, FDA agreed with their recommendations to 
reclassify the device from class III into class II with the recommended 
special controls. Based on the available information, FDA issued an 
order to the petitioner on September 9, 1999, reclassifying the 
nonabsorbable ePTFE

[[Page 20735]]

surgical suture, and substantially equivalent devices of this generic 
type, from class III to class II.
    FDA identified the following FDA recognized consensus standards and 
labeling as special controls for the device:

    1. United States Pharmacopoeia (USP) 21:
    a. Monograph for Nonabsorbable Surgical Sutures;
    b. Suture--Diameter 861>;
    c. Suture--Needle Attachment 871>; and
    d. Tensile Strength 881>.
    2. Labeling:
    a. Contraindication: ``This device is contraindicated for use in 
ophthalmic and neural tissues and for use in microsurgery.''
    b. ``For Single Use Only.''
    c. If the marketed suture has a different diameter than the 
diameter specified in USP 21--Suture Diameter 861>, then a tabular 
comparison of its diameter and USP suture sizes should be included 
in the labeling.

    Accordingly, as required by 21 CFR 860.136(b)(6) of the 
regulations, FDA is announcing the reclassification of the generic 
nonabsorbable ePTFE surgical suture from class III into class II. In 
addition, FDA is codifying the reclassification of the device by adding 
new Sec. 878.5040.

II. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this 
reclassification 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. 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 (Public Law 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 consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the notice 
is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review 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. Reclassification of the device from class III to 
class II will relieve all manufacturers of the device of the cost of 
complying with the premarket approval requirements in section 515 of 
the act (21 U.S.C. 360e). Because reclassification will reduce 
regulatory costs with respect to this device, 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. The agency therefore certifies that this final rule will not 
have a significant economic impact on a substantial number of small 
entities. In addition, this final rule will not impose costs of $100 
million or more on either the private sector or state, local, and 
tribal governments in the aggregate, and therefore a summary statement 
or analysis under section 202(a) of the Unfunded Mandates Reform Act of 
1995 is not required.

IV. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no information that is 
subject to review by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995. The special controls do not require 
the respondent to submit additional information to the public. 
Therefore, no burden is placed on the public.

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 878.5035 is added to subpart E to read as follows:


Sec. 878.5035  Nonabsorbable expanded polytetrafluoroethylene surgical 
suture.

    (a) Identification. Nonabsorbable expanded polytetrafluoroethylene 
(ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, 
flexible thread prepared from ePTFE and is intended for use in soft 
tissue approximation and ligation, including cardiovascular surgery. It 
may be undyed or dyed with an approved color additive and may be 
provided with or without an attached needle(s).
    (b) Classification. Class II (special controls). FDA recognized 
consensus standards and device-specific labeling:
    (1) United States Pharmacopoeia (USP) 21:
    (i) Monograph for Nonabsorbable Surgical Sutures;
    (ii) Sutures--Diameter 861>;
    (iii) Sutures Needle Attachment 871>; and
    (iv) Tensile Strength 881>.
    (2) Labeling:
    (i) Contraindication: ``This device is contraindicated for use 
in ophthalmic and neural tissues and for use in microsurgery.''
    (ii) ``For Single Use Only.''
    (iii) If the marketed suture has a different diameter than the 
diameter specified in USP 21--Suture Diameter 861>, then a tabular 
comparison of its diameter and USP sizes should be included in the 
labeling.

    Dated: April 5, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-9577 Filed 4-17-00; 8:45 am]
BILLING CODE 4160-01-F