E7-13162. Draft Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New Drug Applications for Products Intended to Repair or Replace Knee Cartilage; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage” dated July 2007. The draft guidance provides to sponsors recommendations about certain information that should be included in an investigational device exemption (IDE) or investigational new drug application (IND) for a product intended to repair or replace knee cartilage. The draft guidance, when finalized, will supplement other FDA publications on IDEs and INDs.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 9, 2007.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448; or the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) (HFZ-220), Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800; or by calling CDRH at 240-276-3150 or by faxing a request to CDRH at 240-276-3151. To receive an electronic copy, send an e-mail request to [e-mail]. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.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.

FOR FURTHER INFORMATION CONTACT:

Brenda R. Friend, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210; or

Aric D. Kaiser, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3676.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft document entitled “Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage” dated July 2007. The draft guidance document provides to sponsors recommendations about certain information that should be included in an IDE or IND for a product intended to repair or replace knee cartilage. For the purposes of the draft guidance, a product intended to repair or replace knee cartilage, as with other articular cartilage repair or replacement products, may include a biologic, device, or combination product whose components would be individually regulated by CDRH and CBER.

FDA prepared this draft guidance to address issues that may arise in the development of articular cartilage repair or replacement products. The draft guidance also reflects input received from the public and the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) at the March 3 to 4, 2005, CTGTAC meeting. The draft guidance, when finalized, will supplement other FDA publications on IDEs and INDs.

The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on this topic. 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 requirement of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 (on INDs) have been approved under OMB control number 0910-0014; and those in 21 CFR part 812 (on IDEs) have been approved under OMB control number 0910-0078.

III. Comments

The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance. 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 the brackets in the heading of this document. A copy of the draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/​cber/​guidelines.htm,, http://www.fda.gov/​cdrh/​guidance.html, or http://www.fda.gov/​ohrms/​dockets/​default.htm.

Dated: June 26, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.