Food and Drug Administration, HHS.
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.
Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.
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.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
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 Start Printed Page 22055800-899-0381 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@example.com. 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.
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.Start Signature
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