[Federal Register: April 30, 2002 (Volume 67, Number 83)]
[Notices]
[Page 21256]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap02-80]
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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