[Federal Register Volume 66, Number 173 (Thursday, September 6, 2001)]
[Notices]
[Pages 46641-46642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22287]


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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Medical Devices; Draft Guidance; Class II Special Controls 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availability of the draft guidance entitled ``Class II Special Controls 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 This draft guidance document was developed as 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 This draft 
guidance is neither final nor is it in effect at this time.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diskette of the draft guidance document entitled ``Class II Special 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    Submit written comments concerning this draft guidance to the 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