[Federal Register Volume 67, Number 83 (Tuesday, April 30, 2002)]
[Notices]
[Page 21256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10510]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0318]


Medical Devices; 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 guidance entitled ``Class II Special Controls 
Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or 
Uncemented Prosthesis.'' Elsewhere in this issue of the Federal 
Register, FDA is issuing a final rule to reclassify this type of device 
into class II.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance entitled ``Class II Special Controls Guidance 
Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented 
Prosthesis'' to the Division of Small Manufacturers, International, and 
Consumer Assistance (HFZ-220), Center for Devices and Radiological 
Health (CDRH), Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850. Send two self-addressed adhesive labels to assist 
that office in processing you request, or fax your request to 301-443-
8818. Submit written comments on the guidance 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. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

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

    In the Federal Register of September 6, 2001 (66 FR 46641), FDA 
published a proposed rule to reclassify the hip joint metal/polymer 
constrained cemented or uncemented prosthesis from class III (premarket 
approval) to class II (special controls) based on new information 
regarding this device contained in a reclassification petition 
submitted by the Orthopedic Surgical Manufacturers Association. FDA 
also identified the document ``Class II Special Controls Guidance 
Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented 
Prosthesis'' as the special control capable of providing reasonable 
assurance of safety and effectiveness for this device.
    Interested persons were invited to comment on the draft guidance by 
December 5, 2001. FDA received three comments. Two comments commended 
FDA's proposal to reclassify these devices and agreed that the guidance 
proposed as the special control was adequate to provide reasonable 
assurance of the safety and effectiveness of the device. One comment 
stated that FDA's proposed special control was inadequate to protect 
against certain types of device failure, specifically shell-bone 
interface failure that may occur after implantation of this highly 
constrained device.
    FDA agrees that shell-bone interface failure may occur after 
implantation of the device. FDA has revised the precaution section in 
the guidance document to clarify that it addresses device failure at 
the shell-bone interface.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
agency's current thinking on special controls for 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 statutes and regulations.

III. Electronic Access

    In order to receive the guidance entitled ``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 (1393) 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. Updated on a regular basis, 
the CDRH home page 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 device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://www.fda.gov/ohrms/dockets.

IV. Comments

    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (see ADDRESSES). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 15, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-10510 Filed 4-29-02; 8:45 am]
BILLING CODE 4160-01-S