[Federal Register: September 6, 2001 (Volume 66, Number 173)]
[Notices]
[Page 46641-46642]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06se01-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0318]
Medical Devices; Draft Guidance; Class II Special Controls
Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or
Uncemented Prosthesis; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or
Uncemented Prosthesis.'' This draft guidance document was developed as
a special control guidance to support the reclassification of the hip
joint metal/polymer constrained cemented or uncemented prosthesis into
class II. Elsewhere in this issue of the Federal Register, FDA is
publishing a proposed rule to reclassify this device type. This draft
guidance is neither final nor is it in effect at this time.
DATES: Submit written or electronic comments concerning this guidance
by December 5, 2001.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance document entitled ``Class II Special
Controls Guidance Document: Hip Joint Metal/Polymer Constrained
Cemented or Uncemented Prosthesis'' to the Division of Small
Manufacturers Assistance (HFZ-220), Center for Devices and Radiological
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850. Send two self-addressed adhesive labels to assist that office in
processing your request, or fax your request to 301-443-8818. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit written comments concerning this draft guidance to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Comments are to be
identified with the docket number found in the brackets in the heading
of this document. Submit electronic comments to http://www.fda.gov/
dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: John S. Goode, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2036.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document was developed as a special control
guidance to support the reclassification of the hip joint metal/polymer
constrained cemented or uncemented prosthesis into class II. Elsewhere
in this issue of the Federal Register, FDA is publishing a proposed
rule to reclassify this device type. This draft guidance may not be
implemented until the reclassification process undergoes notice and
comment and completes final rulemaking to reclassify this device. If a
final rule to reclassify this device type is not issued, this guidance
document will not be issued as a special control.
FDA believes that special controls, when combined with the general
controls, will be sufficient to provide reasonable assurance of the
safety and effectiveness of the hip joint metal/polymer constrained
cemented or uncemented prosthesis. If the device is reclassified, a
manufacturer who intends to market a device of this generic type must:
(1) Conform with the general controls of the Federal Food, Drug, and
Cosmetic Act (the act), including the premarket notification
requirements described in FDA regulations (21 CFR 807.81); (2) address
the specific risks to health associated with the hip joint metal/
polymer constrained cemented or uncemented prosthesis; and (3) receive
a substantial equivalence determination from FDA prior to marketing the
device.
This special control draft guidance document identifies the
classification, product code, and classification definition for the
generic hip joint metal/polymer constrained cemented or uncemented
prosthesis. In addition, it identifies the risks to health and serves
as a special control that, when followed and combined with the general
controls, will generally address the risks associated with this generic
device type and lead to a timely section 510(k) of the act (21 U.S.C.
360(k)) review and clearance.
II. Significance of Guidance
This draft guidance document represents the agency's current
thinking about the hip joint metal/polymer constrained cemented or
uncemented prosthesis. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
applicable statute and regulations.
The agency has adopted good guidance practices (GGPs), and
published the final rule, which set forth the agency's regulations for
the development, issuance, and use of guidance documents (21 CFR
10.115; 65 FR 56468, September 19, 2000). This draft guidance document
is issued as a level 1 guidance in accordance with the GGP regulations.
III. Electronic Access
In order to receive ``Class II Special Controls Guidance Document:
Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis''
via your fax machine, call the CDRH Facts-On-Demand system at 800-899-
0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the
system. At the second voice prompt press 1 to order a document. Enter
the document number (1328) followed by the pound sign (#). Follow the
remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the draft guidance may
also do so using the Internet. CDRH maintains an entry on the Internet
for easy access to information including text, graphics, and files that
may be downloaded to a personal computer with Internet access. Updated
on a regular basis, the CDRH home page includes the civil money penalty
guidance documents package, 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 device-oriented
information. The CDRH home page may be accessed at http://www.fda.gov/
cdrh. Guidance documents are also available on the Dockets Management
Branch Internet site at http://www.fda.gov/ohrms/dockets/default.htm.
IV. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written or electronic comments regarding this draft
guidance on or before [insert date 90 days after date of publication in
the Federal Register]. Submit two copies of any comments, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this
[[Page 46642]]
document. The draft guidance document and received comments may be seen
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: August 22, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 01-22287 Filed 9-5-01; 8:45 am]
BILLING CODE 4160-01-S