[Federal Register Volume 70, Number 81 (Thursday, April 28, 2005)]
[Notices]
[Pages 22054-22055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8468]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0178]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Dental Bone Grafting 
Material Devices; 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: Dental Bone Grafting Material Devices.'' This 
guidance document describes a means by which class II dental bone 
grafting material devices may comply with the requirement of special 
controls. Elsewhere in this issue of the Federal Register, FDA is 
publishing a final rule to reclassify tricalcium phosphate (TCP) 
granules for dental bone repair from class III (premarket approval) to 
class II (special controls), classify into class II (special controls) 
other bone grafting material for dental indications, and revise the 
classification name and identification of the device.

DATES: Submit written or electronic comments on this guidance at any 
time. 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 guidance document entitled ``Class II Special Controls 
Guidance Document: Dental Bone Grafting Material Devices'' 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 one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (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.

FOR FURTHER INFORMATION CONTACT: Michael E. Adjodha, Center for Devices 
and Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 30, 2004 (69 FR 39485), FDA 
announced the availability of a draft of this special controls guidance 
document and invited interested persons to comment on it by September 
28, 2004. In addition, in the same Federal Register (69 FR 39377), FDA 
proposed to reclassify tricalcium phosphate (TCP) granules for dental 
bone repair from class III to class II (special controls). 
Concurrently, FDA proposed to classify into class II (special controls) 
all other bone grafting material for dental indications, except those 
that contained a drug or biologic component; and to revise the 
classification name and identification of the device. In the proposed 
rule, FDA identified bone grafting material as a material such as 
hydroxyapatite, tricalcium phosphate, polylactic acids, or collagen, 
intended to fill, augment, or reconstruct periodontal or bony defects 
of the oral and maxillofacial region. FDA received one comment on the 
proposed rule and draft special controls guidance document. The comment 
is addressed in the final rule published elsewhere in this issue of the 
Federal Register.
    The final rule published elsewhere in this issue of the Federal 
Register reclassifies tricalcium phosphate (TCP) granules for dental 
bone repair from class III (premarket approval) to class II (special 
controls) and also classifies other dental bone grafting materials that 
do not contain a drug that is a therapeutic biologic into class II 
(special controls). Bone grafting material devices that contain a drug 
that is a therapeutic biologic will remain in class III and continue to 
require premarket approval. The guidance document provides a means by 
which the dental bone grafting materials in class II may comply with 
the requirement of special controls for class II devices.
    Following the effective date of the final rule, any firm submitting 
a 510(k) for the class II devices will need to address the issues 
covered in the 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.

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 class II dental bone grafting material 
devices. 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.

III. Electronic Access

    To receive ``Class II Special Controls Guidance Document: Dental 
Bone Grafting Material Devices'' by fax, call the CDRH Facts-On-Demand 
system at

[[Page 22055]]

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 (1512) followed by the pound sign 
(). Follow the remaining voice prompts to complete your 
request.
    To receive a hard copy or electronic copy of ``Class II Special 
Controls Guidance Document: Dental Bone Grafting Material Devices,'' 
you may either send a fax request to 301-443-8818, or send an e-mail 
request to [email protected]. Please use the document number (1512) to 
identify the guidance you are requesting.
    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 with Internet access. 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 Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. 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 OMB control number 0910-
0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: April 4, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-8468 Filed 4-27-05; 8:45 am]
BILLING CODE 4160-01-S