[Federal Register: June 2, 2003 (Volume 68, Number 105)]
[Notices]
[Page 32761-32762]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn03-91]
-----------------------------------------------------------------------
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