[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