[Federal Register Volume 67, Number 244 (Thursday, December 19, 2002)]
[Proposed Rules]
[Pages 77698-77701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31991]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 67, No. 244 / Thursday, December 19, 2002 / 
Proposed Rules  

[[Page 77698]]



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: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the classification regulations for eight surgical suture devices 
previously reclassified into class II, in order to specify a special 
control for those devices. FDA is proposing the guidance document 
``Class II Special Controls Guidance Document: Surgical Sutures; 
Guidance for Industry and FDA'' as the special control that the agency 
believes will reasonably assure the safety and effectiveness of the 
devices, and FDA is announcing the availability for comment of that 
guidance document elsewhere in this issue of the Federal Register. 
Elsewhere in this issue of the Federal Register, FDA is also publishing 
a final rule reclassifying the absorbable polydioxanone surgical (PDS) 
suture from class III (premarket approval) to class II (special 
controls), and is designating as the special control for that device, 
effective immediately, the same guidance document here proposed as the 
special control for the eight surgical sutures devices covered by this 
proposed rule. After public comments are reviewed, FDA intends to issue 
a final rule for the eight surgical sutures covered by this proposed 
rule, making the guidance effective as the special control guidance for 
those sutures in addition to the PDS suture. Following the effective 
date of such final rule, any firm submitting a premarket notification 
(510(k)) for a new surgical suture will need to address the issues 
covered in the special control guidance. However, the firm needs only 
to show that its device meets the recommendations of the guidance or in 
some other way provides equivalent assurance of safety and 
effectiveness.

DATES: Submit written or electronic comments on the proposed rule by 
March 19, 2003. See section VI of this document for the proposed 
effective date of a final rule based on this document.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

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

    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 
(SMDA) (Public Law 101-629), and the Food and Drug Administration 
Modernization Act (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.
    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 
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 into class III all transitional devices, i.e., 
those devices previously regulated as new drugs, including surgical 
sutures.
    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).

II. Regulatory History of the Devices

    In accordance with section 520(l)(2) of the act and Sec.  860.136, 
FDA, after consulting with members of the General and Plastic Surgery 
Devices Panel, reclassified certain surgical suture devices in part 878 
(21 CFR 878) from class III to class II as follows:
    1. Absorbable poly(glycolide/L-lactide) surgical suture (Sec.  
878.4493), reclassification order (letter) dated September 14, 1989;
    2. Stainless steel suture (Sec.  878.4495), reclassification order 
(letter) dated July 30, 1986;
    3. Absorbable surgical gut suture (Sec.  878.4830), 
reclassification order (letter) dated September 19, 1988;
    4. Nonabsorbable poly(ethylene terephthalate) surgical suture 
(Sec.  878.5000), reclassification order (letter) dated July 5, 1990;
    5. Nonabsorbable polypropylene surgical suture (Sec.  878.5010), 
reclassification order (letter) dated July 5, 1990;

[[Page 77699]]

    6. Nonabsorbable polyamide surgical suture (Sec.  878.5020), 
reclassification order (letter) dated February 15, 1990;
    7. Natural nonabsorbable silk surgical suture (Sec.  878.5030), 
reclassification order (letter) dated November 9, 1990; and
    8. Nonabsorbable expanded polytetrafluoroethylene surgical suture 
(Sec.  878.5035), reclassification order (letter) dated September 9, 
1999.

III. Proposed Rule

    FDA is proposing to amend the classification regulations for the 
foregoing eight surgical suture devices in order to designate a special 
control for each device. With the exception of the nonabsorbable 
expanded polytetrafluoroethylene surgical suture, all of the 
transitional surgical suture devices were reclassified before the 
provisions of SMDA became effective that broadened the definition of 
class II devices to establish special controls beyond performance 
standards. Thus, developing device-specific guidance as the means to 
provide reasonable assurance of the safety and effectiveness of the 
device was not a regulatory option at the time of their original 
reclassification. No mandatory performance standard has been developed 
for these devices.
    Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical 
sutures were reclassified from class III to class II (special controls) 
and special controls were identified, including device-specific 
labeling and FDA-recognized consensus standards.
    FDA has developed a guidance document for surgical suture devices 
and, under the SMDA authority, is now proposing to apply it as the 
special control the agency believes will reasonably assure the safety 
and effectiveness of these devices. FDA is identifying the guidance 
document entitled ``Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and FDA'' as the proposed 
special control. The special controls included in the guidance document 
are the same as those identified in the Code of Federal Regulations 
(CFR) for ePTFE surgical sutures with one exception. The consensus 
standard identified in 21 CFR 878.5035 as United States Pharmacopoeia 
(U.S.P.) 21 has been updated in the guidance to ``the currently 
recognized USP standard'' to reflect the fact that the compendium of 
U.S.P. standards is now published yearly. In the past, it was published 
only every 5 years, U.S.P. 21 having been the 1985 publication.

IV. Risks to Health

    FDA has identified the following risks to health associated with 
the use of surgical sutures: Improper selection and use, suture 
breakage, adverse tissue reaction, and infection.

A. Improper Selection and Use

    Proper selection of the size and type of suture most suitable for 
the type of tissue and surgical site depends on the performance of the 
suture, the material composition, absorbability (and if absorbable, the 
rate of absorption), tensile strength (and changes in tensile strength 
over time), and/or specific instructions for certain types of sutures, 
tissues, or surgical sites (e.g., ``Prolonged contact with bile or 
urine may result in calculus formation.''). Improper selection and use 
can result in:
    [sbull] Wound dehiscence (splitting open of the sutured tissue),
    [sbull] Unsatisfactory appearance of the surgical scar, or
    [sbull] Impaired function or mobility at the surgical site.
Any of these events may result in the patient having to undergo another 
surgical procedure.

B. Suture Breakage

    The intended use of a surgical suture is to successfully hold 
tissue together until healing is sufficiently complete. Suture breakage 
before the sutured wound heals can result in wound dehiscence. This may 
interfere with the normal healing process and/or result in the patient 
having to undergo another surgical procedure.

C. Adverse Tissue Reaction

    An adverse tissue reaction to the surgical suture is a potential 
risk to health generally associated with all surgical sutures if 
biocompatibility, toxicity, and immunogenicity of the sutures are not 
adequately addressed. An adverse tissue reaction may result from:
    [sbull] Foreign body reaction to the suture material;
    [sbull] Toxicity of nonbiocompatible materials (dyes, coatings);
    [sbull] Cytotoxic levels of sterilization residues;
    [sbull] Absorbable suture materials that are absorbed too quickly 
or too slowly, producing a toxic response; or
    [sbull] A local or systemic allergic reaction in patients with an 
abnormal sensitivity to the suture material, dye or coating.

D. Infection

    Infection is a potential risk to health generally associated with 
all surgical procedures and implanted devices. Infection can result 
from:
    [sbull] Inadequate sterilization of the surgical suture,
    [sbull] Failure of the packaging to maintain sterility, or
    [sbull] Contamination after the package is opened.
Preventative measures, including implantation of a sterile device and 
strict adherence to accepted sterile technique are the best defenses 
against infection.

V. Special Controls

    FDA believes that in addition to general controls, the class II 
special control guidance document entitled ``Class II Special Controls 
Guidance Document: Surgical Sutures; Guidance for Industry and FDA'' is 
an adequate special control to address the risks to health associated 
with surgical sutures and thus provide reasonable assurance of the 
safety and effectiveness of the device. The class II special controls 
guidance document provides information on how to meet premarket 
notification (510(k)) submission requirements for surgical sutures, 
including recommendations regarding device description, preclinical 
data, clinical data, color additives, sterilization, and labeling. It 
identifies voluntary consensus standards that address surgical suture 
specifications and performance, material biocompatibility and 
sterilization, and FDA guidance documents that address material 
biocompatibility and sterilization:
    The class II special controls guidance document addresses the risks 
to health associated with surgical sutures in the following four ways:
    [sbull] Adherence to the labeling recommendations in the guidance 
addresses the risk of improper suture selection and use by ensuring 
that users have adequate information on suture performance, material 
composition, absorbability (and if absorbable, the rate of absorption) 
and changes in tensile strength over time, to select the proper size 
and type of suture for the type of tissue and surgical site;
    [sbull] Adherence to the voluntary consensus standards recommended 
in the guidance addresses the risk of surgical suture breakage by 
ensuring that surgical sutures have adequate tensile strength, 
diameter, and needle attachment strength;
    [sbull] Adherence to the biocompatibility testing recommendations 
and biocompatibility standards in the guidance addresses the risk of an 
adverse tissue reaction by ensuring that the surgical sutures are made 
of

[[Page 77700]]

materials with adequate biocompatibility and that the absorbable 
surgical suture materials have appropriate pharmacokinetic properties; 
and
    [sbull] Adherence to the sterilization guidance and the voluntary 
consensus standards recommended in the guidance document addresses the 
risk of infection by ensuring that the surgical suture is sterile and 
has adequate packaging to maintain sterility.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice of availability of the guidance document entitled ``Class II 
Special Controls Guidance Document: Surgical Sutures; Guidance for 
Industry and FDA.'' This guidance document is proposed as the special 
control for these eight surgical sutures and is not yet final or in 
effect as to these sutures. After public comments on this proposed rule 
and on the guidance document are reviewed, FDA intends to issue a final 
rule for these eight surgical sutures and the guidance document will 
become final and effective as the special control guidance for them. 
Following the effective date of such final rule, any firm submitting a 
premarket notification (510(k)) for a new surgical suture will need to 
address the issues covered in the special control guidance. However, 
the firm needs only to show that its device meets the recommendations 
of the guidance or in some other way provides equivalent assurance of 
safety and effectiveness. Also, elsewhere in this issue of the Federal 
Register, FDA is publishing a final rule reclassifying the absorbable 
PDS suture from class III (premarket approval) to class II (special 
controls), and designating the same guidance document as the special 
control for that device. The special control guidance document is 
immediately in effect as the special control for the PDS suture only, 
but as to that suture remains subject to public comment and possible 
future revision under the agency's good guidance practices.

VI. Proposed Effective Date

    FDA proposes that any final rule that may issue based on this 
proposal become effective 30 days after its date of publication in the 
Federal Register.

VII. 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.

VIII. Analysis of Impacts

    FDA has examined the impacts of the proposed 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 proposed 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, if this rule is finalized. 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 proposed 
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.

IX. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collections of information. Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(the PRA) (44 U.S.C. 3501-3520) is not required.
    The information collections addressed in the special control 
guidance document identified by this proposed rule have been approved 
by OMB in accordance with the PRA under the regulations governing 
premarket notification submissions (21 CFR part 807, subpart E, OMB 
control number 0910-0120).

X. Submission of Comments

    You may submit to the Dockets Management Branch (see ADDRESSES) 
written or electronic comments regarding this guidance by March 19, 
2003. You should submit two copies of any comments. Individuals may 
submit one copy. You must identify comments with the docket number 
found in brackets in the heading of this document. The guidance 
document and comments received may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

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, it is 
proposed that 21 CFR part 878 be 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 878.4493 is amended by revising paragraph (b) to read as 
follows:


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

* * * * *

[[Page 77701]]

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


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 document.
    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.
    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.
    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: October 16, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-31991 Filed 12-18-02; 8:45 am]
BILLING CODE 4160-01-S