[Federal Register Volume 67, Number 26 (Thursday, February 7, 2002)]
[Notices]
[Pages 5832-5833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3018]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 91D-0407]


Draft Guidance for Industry and FDA on Class II Special Controls 
Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; 
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availability of a draft guidance entitled ``Class II Special Controls 
Guidance Document: Resorbable Calcium Salt Bone Void Filler Device.'' 
This draft guidance is intended to support the classification of the 
resorbable calcium salt bone void filler device. Elsewhere in this 
issue of the Federal Register, FDA is issuing a proposed rule to 
classify the resorbable calcium salt bone void filler device into class 
II. This draft guidance is neither final nor is it in effect at this 
time.

DATES: Submit written or electronic comments on the draft guidance by 
May 8, 2002. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance entitled ``Class II Special Controls Guidance 
Document: Resorbable Calcium Salt Bone Void Filler Device'' 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 your 
request, or fax your request to 301-443-8818. Submit written comments 
on the draft guidance to the Dockets Management Branch (HFA-305), Food 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access to the draft guidance.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

    This draft guidance was developed as a special control guidance to 
support the classification of the resorbable calcium salt bone void 
filler device into class II. FDA is proposing to classify this device 
elsewhere in this issue of the Federal Register. This guidance may not 
be implemented until the agency completes notice and comment rulemaking 
to classify the device. If a final rule to classify 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 resorbable calcium salt bone void 
filler device. If the device is classified into class II, 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, including the section 510(k) requirements (21 U.S.C. 
360(k)) described in 21 CFR 807.81; (2) address the specific risks to 
health associated with use of the device; and (3) receive a substantial 
equivalence determination from FDA prior to marketing the device.
    The draft guidance 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 type of 
generic device.

II. Significance of Guidance

    This draft guidance represents the agency's current thinking about 
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 an 
approach satisfies the applicable statute and regulations.
    The agency has adopted good guidance practices (GGPs), which set 
forth the agency's regulations for the development, issuance, and use 
of guidance documents (21 CFR 10.115). This draft guidance is issued as 
a level 1 draft guidance consistent with the GGP regulations.

III. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document: 
Resorbable Calcium Salt Bone Void Filler Device'' via your fax machine, 
call

[[Page 5833]]

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 draft guidance may 
also do so using the Internet. CDRH maintains an entry on the Internet 
for easy access to information, including the 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 guidances document 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 Web 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 by May 8, 2002. 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 draft guidance and received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: October 5, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-3018 Filed 2-6-02; 8:45 am]
BILLING CODE 4160-01-S