[Federal Register Volume 68, Number 106 (Tuesday, June 3, 2003)]
[Rules and Regulations]
[Pages 32983-32985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13825]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. 02N-0288]


Medical Devices; Designation of Special Control for Eight 
Surgical Suture Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
to amend the classification regulations for eight surgical suture 
devices previously reclassified into class II to specify a special 
control for those devices. The special control is an FDA guidance 
document entitled ``Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and FDA'' that identifies 
performance, testing, and labeling recommendations for the devices. 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of the guidance document that will serve as the special 
control. FDA is taking these actions on its own initiative because it 
believes they are necessary to provide reasonable assurance of the 
safety and effectiveness of surgical suture devices. These actions are 
being taken under the Federal Food, Drug, and Cosmetic Act (the act).

DATES: This rule is effective July 3, 2003.

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, ext. 164.

SUPPLEMENTARY INFORMATION:

I. Background

    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 (SMDA) (Public Law 101-629), the Food and 
Drug Administration Modernization Act (FDAMA) (Public Law 105-115), and 
the Medical Device User Fee and Modernization Act (MDUFMA) (Public Law 
107-250) 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.
    SMDA broadened the definition of class II devices to mean those 
devices for which the general controls by themselves are insufficient 
to provide reasonable assurance of 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 also 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 into class III all transitional devices, i.e., those devices 
previously regulated as new drugs, including surgical sutures.

II. Regulatory History of the Devices

    In the Federal Register of December 16, 1977 (42 FR 63472), FDA 
published a notice that identified sutures as class III devices under 
the transitional provisions of the act. Section 520(l)(2) of the act 
(21 U.S.C. 360j(l)(2)) provides that the manufacturer or importer of a 
device classified in class III under the transitional provisions may 
file a petition for reclassification of the device into class I or 
class II. Procedures for filing and review of classification petitions 
are set forth in Sec.  860.136 (21 CFR 860.136).
    In accordance with section 520(l)(2) of the act and Sec.  860.136, 
and after consulting with members of the General and Plastic Surgery 
Devices Panel, FDA reclassified surgical suture devices from class III 
to class II as follows:
    1. Absorbable poly(glycolide/L-lactide) surgical suture (21 CFR 
878.4493), reclassification order (letter) dated September 14, 1989;
    2. Stainless steel suture (21 CFR 878.4495), reclassification order 
(letter) dated July 30, 1986;
    3. Absorbable surgical gut suture (21 CFR 878.4830), 
reclassification order (letter) dated September 19, 1988;
    4. Nonabsorbable poly(ethylene terephthalate) surgical suture (21 
CFR 878.5000), reclassification order (letter) dated July 5, 1990;
    5. Nonabsorbable polypropylene surgical suture (21 CFR 878.5010), 
reclassification order (letter) dated July 5, 1990;
    6. Nonabsorbable polyamide surgical suture (21 CFR 878.5020), 
reclassification order (letter) dated February 15, 1990;
    7. Natural nonabsorbable silk surgical suture (21 CFR 878.5030), 
reclassification order (letter) dated November 9, 1990; and
    8. Nonabsorbable expanded polytetrafluoroethylene surgical suture 
(21 CFR 878.5035), reclassification order (letter) dated September 9, 
1999.
    In the Federal Register of December 19, 2002 (67 FR 77678), FDA 
published a proposed rule to designate a special control for eight 
surgical suture devices already classified into class II. FDA proposed 
that surgical suture devices would remain in class II, but would be 
subject to a special control. The proposed rule identified the special 
control as an FDA guidance document entitled ``Class II Special 
Controls Guidance Document: Surgical Sutures; Guidance for Industry and 
FDA.'' In the same edition of the Federal Register, FDA announced the 
availability of the draft guidance that, when final, was intended to 
serve as a special control (67 FR 77797). FDA invited interested 
persons to comment on the proposed rule and on the proposed special 
control guidance document by March 19, 2003.

III. FDA's Conclusion

    FDA received no comments on the proposed rule or on the guidance 
document proposed as the special control. Therefore, under the SMDA 
authority, FDA is amending the classification regulations for eight 
surgical suture devices previously reclassified into class II, to 
designate a special control for those devices. The special control 
capable of providing reasonable assurance of safety and effectiveness 
for these devices is a guidance document entitled ``Class II Special 
Controls Guidance Document: Surgical Sutures; Guidance for Industry and 
FDA'' that identifies performance,

[[Page 32984]]

testing, and labeling recommendations for the devices. Elsewhere in 
this issue of the Federal Register, FDA is announcing the availability 
of the special control guidance.
    Following the effective date of this final rule, any firm 
submitting a 510(k) premarket notification for a new surgical suture 
will need to address the recommendations in the special control 
guidance. However, the firm need only show that its device is as safe 
and effective as a device that meets guidance recommendations. The firm 
may use alternative approaches if those approaches address the 
performance, testing, and labeling issues identified in the guidance.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this final 
rule 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.

V. Analysis of Impacts

    FDA has examined the impact 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 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 options that would minimize any significant impact of a rule 
on small entities. The special controls guidance document does not 
impose any new burdens on manufacturers of these devices. FDA has 
granted 201 substantial equivalence orders from 95 manufacturers of 
these devices in the last 10 years. The guidance document is based upon 
the review of the information submitted in these premarket 
notifications. Based on the review of the premarket notifications, FDA 
believes that manufacturers presently marketing these devices are in 
conformance with the guidance document and they will not need to take 
any further action. The guidance document merely assures that, in the 
future, devices of these generic types will be at least as safe and 
effective as the presently marketed devices. These devices are already 
subject to premarket notification and labeling requirements. The 
guidance document advises manufacturers on appropriate means of 
complying with these requirements.
    The consensus standards in the guidance were recognized under 
section 514(c) of the act (21 U.S.C. 360d(c)) for the purpose of 
demonstrating certain aspects of substantial equivalency. The 
manufacturer may provide a declaration of conformity to a recognized 
standard to meet a premarket notification requirement. Ordinarily, this 
will provide a simplified method of meeting the requirement. The 
manufacturer may choose to submit other data or information to meet the 
requirement. The guidance document sets out options that the 
manufacturer has in this respect.
    For the foregoing reasons, the agency certifies that this rule will 
not have a significant economic impact on a substantial number of small 
entities. In addition, this 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.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

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 878.4493 is amended by revising paragraph (b) to read as 
follows:


Sec.  878.4493  Absorbable poly(glycolide/L-lactide) surgical suture.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.  
878.1(e) for the availability of this guidance document.

0
3. Section 878.4495 is amended by revising paragraph (b) to read as 
follows:


Sec.  878.4495  Stainless steel suture.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.  
878.1(e) for the availability of this guidance document.

0
4. Section 878.4830 is amended by revising paragraph (b) to read as 
follows:


Sec.  878.4830  Absorbable surgical gut suture.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.  
878.1(e) for the availability of this guidance document.

0
5. Section 878.5000 is amended by revising paragraph (b) to read as 
follows:


Sec.  878.5000  Nonabsorbable poly(ethylene terephthalate) surgical 
suture.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.  
878.1(e) for the availability of this guidance document.

0
6. Section 878.5010 is amended by revising paragraph (b) to read as 
follows:

[[Page 32985]]

Sec.  878.5010  Nonabsorbable polypropylene surgical suture.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.  
878.1(e) for the availability of this guidance document.

0
7. Section 878.5020 is amended by revising paragraph (b) to read as 
follows:


Sec.  878.5020  Nonabsorbable polyamide surgical suture.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.  
878.1(e) for the availability of this guidance document.

0
8. Section 878.5030 is amended by revising paragraph (b) to read as 
follows:


Sec.  878.5030  Natural nonabsorbable silk surgical suture.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.  
878.1(e) for the availability of this guidance document.

0
9. Section 878.5035 is amended by revising paragraph (b) to read as 
follows:


Sec.  878.5035  Nonabsorbable expanded polytetrafluoroethylene surgical 
suture.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.  
878.1(e) for the availability of this guidance document.

    Dated: May 20, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-13825 Filed 6-2-03; 8:45 am]
BILLING CODE 4160-01-S