[Federal Register Volume 68, Number 105 (Monday, June 2, 2003)]
[Notices]
[Pages 32761-32762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13593]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 91D-0407]


Medical Devices; Class II Special Controls Guidance Document: 
Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry 
and FDA; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; 
Guidance for Industry and FDA.'' This document describes a means by 
which resorbable calcium salt bone void filler devices may comply with 
the requirement for special controls. Elsewhere in this issue of the 
Federal Register, FDA is issuing a final rule to classify the 
resorbable calcium salt bone void filler device into class II (special 
controls).

DATES: Submit written or electronic comments on the guidance at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Class II Special Controls 
Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; 
Guidance for Industry and FDA'' to the Division of Small Manufacturers, 
International, and Consumer 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. Submit written comments concerning this 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. Identify comments with the 
docket number found in brackets in the heading of this document. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Nadine Y. Sloan, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1296.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 7, 2002 (67 FR 5753), FDA 
published a proposed rule to classify the resorbable calcium salt bone 
void filler device into class II (special controls). FDA identified the 
draft guidance document entitled ``Class II Special Controls Guidance: 
Resorbable Calcium Salt Bone Void Filler Device: Draft Guidance for 
Industry and FDA'' as the special control capable of providing 
reasonable assurance of safety and effectiveness for these devices.
    Interested persons were invited to comment on the draft guidance by 
May 8, 2002. FDA received three comments. These comments were 
supportive of the guidance document and made suggestions on the 
guidance's content. Two of the comments also requested clarification of 
the scope and the risks in the guidance document. FDA considered the 
comments and revised the guidance document accordingly. We also 
clarified our labeling recommendations.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on the resorbable calcium salt bone void 
filler device. 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 requirements of the 
applicable statute and regulations.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for a resorbable 
calcium salt bone void filler device will need to

[[Page 32762]]

address the issues covered in the class II 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.

III. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) . 
The collections of information addressed in the guidance document 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). The labeling provisions addressed in 
the guidance have been approved by OMB under the PRA under OMB control 
number 0910-0485.

IV. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES), written or electronic comments regarding this guidance. 
Submit a single copy of electronic comments or two hard copies of any 
mailed 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 document. Received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document: 
Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry 
and FDA'' by 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 (855) followed by the pound sign (). 
Follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so by 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 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site 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 on the Dockets Management Branch Internet site at http://www.fda.gov/ohrms/dockets.

    Dated: April 9, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-13593 Filed 5-30-03; 8:45 am]
BILLING CODE 4160-01-S