[Federal Register: December 19, 2002 (Volume 67, Number 244)]
[Proposed Rules]
[Page 77698-77701]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de02-12]
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Proposed Rules
Federal Register
________________________________________________________________________
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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[[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.
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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