[Federal Register Volume 65, Number 72 (Thursday, April 13, 2000)]
[Rules and Regulations]
[Pages 19835-19836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9129]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. 86P-0087]


Medical Devices; Reclassification and Codification of the 
Stainless Steel 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 Alto Development Corp. 
(the petitioner) reclassifying the 316L stainless steel suture for use 
in abdominal wound closure, intestinal anastomosis, hernia repair, and 
sternal closure from class III (premarket approval) to class II 
(special controls). The order is being codified in the Code of Federal 
Regulations (CFR). Although FDA reclassified the device in 1986, it 
inadvertently neglected to publish a notice of the reclassification in 
the Federal Register or codify the change in the CFR.

DATES: This rule is effective May 15, 2000.

FOR FURTHER INFORMATION CONTACT: Stephen P. Rhodes, 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

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321 
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 (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).
    Under the 1976 amendments, class II devices were defined as those 
devices for which there is insufficient information to show that 
general controls themselves will assure safety and effectiveness, but 
for which there is sufficient information to establish performance 
standards to provide such assurance. The SMDA broadened the definition 
of class II devices to mean those devices for which there is 
insufficient information to show that general controls themselves will 
assure safety and effectiveness, but for which there is sufficient 
information to establish special controls to provide such assurance, 
including performance standards, postmarket surveillance, patient 
registries, development and dissemination of guidelines, 
recommendations, and any other appropriate actions the agency deems 
necessary (section 513(a)(1)(B) of the act).
    The 1976 amendments broadened the definition of ``device'' in 
section 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 stainless steel sutures, 
into class III.
    On December 16, 1977, FDA published a notice in the Federal 
Register (42 FR 63472), that identified sutures as class III devices 
under the transitional provisions of the act for which premarket 
approval is required. Section 520(l)(2) of the act (21 U.S.C. 
360j(l)(2)) provides that, in addition to the Secretary of Health and 
Human Services, the manufacturer or importer of a device classified 
into class III under the transitional provisions, may file a petition 
for reclassification of the device into class I or class II. The 
procedures for filing and review of petitions for reclassification of 
transitional devices are set forth in Sec. 860.136 (21 CFR 860.136).
    On February 21, 1986, FDA filed the petition submitted by the 
petitioner, requesting reclassification of the 316L stainless steel 
sutures from class III to class II. FDA consulted with the General and 
Plastic Surgery Devices Panel (the Panel) regarding reclassification of 
the devices. During an open panel meeting on March 25, 1986, the Panel 
recommended that FDA reclassify the 316L stainless steel sutures 
intended for use in abdominal wound closure, intestinal anastomosis, 
hernia repair, and sternal closure, from class III to class II. In 
addition, the Panel recommended that FDA assign a low priority for the 
development of a performance standard based on the long history of safe 
use of the device and the conformance by stainless steel manufacturers 
to existing voluntary standards.
    After reviewing the data in the petition and presented before the 
Panel, FDA agreed with the Panels recommendation that the 316L 
stainless steel sutures, and substantially equivalent devices of this 
generic type, intended for use in abdominal wound closure, intestinal 
anastomosis, hernia repair, and sternal closure should be reclassified 
from class III to class II, and that the issuance of a performance 
standard for the device would be a low priority.
    On July 30, 1986, FDA issued an order to the petitioner 
reclassifying the 316L stainless steel suture, and substantially 
equivalent devices for this generic type, from class III into class II. 
Inadvertently, FDA neglected to announce the reclassification order in 
the Federal Register.
    Accordingly, as required by Sec. 860.136(b)(6), FDA is announcing 
the reclassification of the generic 316L stainless steel suture from 
class III to class II. In addition, FDA is issuing this final rule to 
codify the reclassification of the device by adding new Sec. 878.4495.

II. Environmental Impact

    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. 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) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121), 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 final rule 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

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options that would minimize any significant impact of a rule on small 
entities. Reclassification of the device from class III to class II has 
relieved 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 has reduced regulatory costs 
with respect to this device, no significant economic impact has been 
imposed on any small entities, and it may have permitted small 
potential competitors to enter the marketplace by lowering their costs. 
The agency therefore certifies that this final rule does 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.

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 878.4495 is added to subpart E to read as follows:


Sec. 878.4495  Stainless steel suture.

    (a) Identification. A stainless steel suture is a needled or 
unneedled nonabsorbable surgical suture composed of 316L stainless 
steel, in USP sizes 12-0 through 10, or a substantially equivalent 
stainless steel suture, intended for use in abdominal wound closure, 
intestinal anastomosis, hernia repair, and sternal closure.
    (b) Classification. Class II (special controls).

    Dated: March 29, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-9129 Filed 4-12-00; 8:45 am]
BILLING CODE 4160-01-F