[Federal Register: December 19, 2002 (Volume 67, Number 244)]
[Rules and Regulations]
[Page 77675-77677]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de02-6]
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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