[Federal Register Volume 67, Number 244 (Thursday, December 19, 2002)]
[Rules and Regulations]
[Pages 77675-77677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31993]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. 99P-5589]


Medical Devices; Reclassification and Codification of the 
Absorbable Polydioxanone 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 Ethicon, Inc., 
reclassifying the absorbable polydioxanone surgical (PDS) suture 
intended for use in soft tissue approximation, including use in 
pediatric cardiovascular tissue where growth is expected to occur and 
ophthalmic surgery, from class III (premarket approval) to class II 
(special controls). Elsewhere in this issue of the Federal Register, 
FDA is announcing the availability of the guidance document entitled 
``Class II Special Controls Guidance Document: Surgical Sutures; 
Guidance for Industry and FDA,'' which is immediately in effect as the 
special control for the PDS suture, but remains subject to public 
comment and possible future revision under the agency's good guidance 
practices. The agency is reclassifying this device into class II 
because new information supplied by the petitioner indicates that 
special controls, in addition to general controls, will provide 
reasonable assurance of the safety and effectiveness of the device, and 
there is sufficient information to establish special controls. 
Accordingly, the order is being codified in the Code of Federal 
Regulations. Any firm submitting a premarket notification (510(k)) for 
a new PDS suture will need to address the issues covered in the special 
control guidance. However, the firm need only show that its device 
meets the recommendations of the guidance or in some other way provides 
equivalent assurances of safety and effectiveness.

DATES: This rule is effective January 21, 2003. The reclassification 
was effective September 4, 2001.

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 
(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) establishes 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 
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 the 
absorbable PDS suture. 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 Device

    Under section 520(l)(2) of the act and Sec.  860.136, on August 25, 
1999, FDA filed a petition submitted by Ethicon, Inc., requesting 
reclassification of the absorbable PDS suture from class III to class 
II. Class II devices are 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). FDA consulted with members of the General and 
Plastic Surgery Devices Panel (the Panel members) regarding 
reclassification of the absorbable PDS suture. The Panel members 
recommended that FDA reclassify the absorbable PDS suture for soft 
tissue approximation, including use in pediatric cardiovascular tissue 
where growth is expected to occur, and ophthalmic surgery, from class 
III to class II. The Panel members also recommended consensus standards 
and device-specific labeling as the special controls that could 
reasonably assure the safety and effectiveness of the device.

III. FDA's Conclusion

    FDA considered the Panel members' recommendations that the generic 
type of device, the absorbable PDS suture for soft tissue 
approximation, be reclassified from class III to class II. After 
reviewing the data in the petition and after considering the Panel 
members' recommendations and the comments, FDA, based on the 
information set forth, issued an order to the petitioner on September 
4, 2001, reclassifying the absorbable PDS suture, and substantially 
equivalent devices of this generic type, from class III to class II. 
Accordingly, as required under Sec.  860.136(b)(6), FDA is announcing 
the reclassification of the generic absorbable PDS suture from class 
III (premarket approval) into class II (special controls). The special 
control capable of providing reasonable assurance of safety and 
effectiveness for this device is a guidance document entitled ``Class 
II Special Controls Guidance Document: Surgical Sutures; Guidance for 
Industry and FDA,'' which FDA is making available elsewhere in this 
issue of the Federal Register. The guidance document describes a means 
by which surgical suture devices may comply with the requirement of 
special controls for class II devices. Any firm submitting a premarket 
notification (510(k)) for a new PDS 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 assurances of safety and 
effectiveness. The special control guidance document reframes the risks 
identified in the PDS reclassification order to better show how the 
mitigating measures recommended by the guidance are associated with 
each risk. The clinical sequelae of the risks identified in the order 
and of the risks identified in the guidance are identical. FDA notes 
that the class II special control guidance document incorporates 
consensus

[[Page 77676]]

standards and device-specific labeling. FDA is codifying the 
reclassification of the device by adding Sec.  878.4840.
    For the convenience of the readers, FDA is adding 21 CFR 878.1(e) 
to inform the readers where they may find guidance documents referenced 
in 21 CFR part 878.

IV. Electronic Access

    Guidance documents are available from the Division of Small 
Manufacturers, International, and Consumer Assistance (DSMICA) (HFZ-
220), Food and Drug Administration, Center for Devices and Radiological 
Health, 1350 Piccard Dr., Rockville, MD 20850. To receive the guidance 
document via your fax machine, telephone the CDRH Facts-On-Demand (FOD) 
system at 800-899-0381 or 301-827-0111 from a touch tone telephone. 
Press 1 to enter the system and enter the document number (1387) 
followed by the pound sign ([numsign]). Follow the remaining voice 
prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. The Center for Devices and Radiological Health 
(CDRH) maintains a home page on the Internet at http://www.fda.gov/cdrh 
for easy access to information that may be downloaded to a personal 
computer. Updated on a regular basis, the CDRH Internet site includes 
device safety alerts; Federal Register reprints; information on 
premarket submissions, including lists of approved applications and 
manufacturers' addresses; small manufacturers' assistance; information 
on video conferencing and electronic submissions; Mammography Matters; 
and other medical device-oriented information. A search capability for 
all guidance documents may be found at http://www.fda.gov/cdrh/guidance.html.

V. 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.

VI. 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 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 options that would minimize any significant impact of a rule 
on small entities. Reclassification of the device from class III to 
class II relieves 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). There was only one manufacturer of this 
device at the time FDA reclassified it. Subsequently, FDA has found 
another manufacturer's device to be substantially equivalent to the 
reclassified device. The special controls guidance document does not 
impose any new burdens on these or future manufacturers. It merely 
assures that, in the future, devices of this generic type 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 merely advises manufacturers on 
appropriate means of complying with these requirements. Furthermore, 
this rule may permit small potential competitors to enter the 
marketplace by lowering their costs. The agency, therefore, 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.

VII. 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.

VIII. Paperwork Reduction Act of 1995

    This final 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 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).

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 878.1 is amended by adding a paragraph (e) to read as 
follows:


Sec.  878.1  Scope.

* * * * *
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/cdrh/guidance.html.
    3. Section 878.4840 is added to subpart E to read as follows:


Sec.  878.4840   Absorbable polydioxanone surgical suture.

    (a) Identification. An absorbable polydioxanone surgical suture is 
an absorbable, flexible, sterile, monofilament thread prepared from 
polyester polymer poly (p-dioxanone) and is intended for use in soft 
tissue approximation, including pediatric cardiovascular tissue where 
growth is expected to occur, and ophthalmic surgery. It may be coated 
or uncoated, undyed or dyed, and with or without a standard needle 
attached.
    (b) Classification. Class II (special controls). The special 
control for the 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.


[[Page 77677]]


    Dated: October 16, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-31993 Filed 12-18-02; 8:45 am]
BILLING CODE 4160-01-S