Notice: Guidance for Industry: Preparation of Investigational Device 
Exemptions and Investigational New Drug Applications for Products 
Intended To Repair or Replace Knee Cartilage; Availability

Federal Register: Volume 77, Number 11 (Wednesday, January 18, 2012)
                  Pages 2555-2556

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: 
Preparation of IDEs and INDs for Products Intended to Repair or Replace 
Knee Cartilage'' dated December 2011. The guidance document provides 
sponsors of an investigational device exemption application (IDE) or an 
investigational new drug application (IND) recommendations about 
certain information that should be included in

[[Page 2556]]

a submission describing a product intended to repair or replace knee 
cartilage. The guidance does not apply to prostheses such as 
unicondylar or total knee implants, or meniscus replacement products. 
The guidance supplements recommendations regarding IDE and IND 
submissions contained in other FDA publications. The guidance announced 
in this notice finalizes the draft guidance of the same title dated 
July 2007.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development (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, Center for Devices and Radiological Health (CDRH), 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 
4613, Silver Spring, MD 20993. Send one self-addressed adhesive label 
to assist the office in processing your requests. The guidance may also 
be obtained by mail by calling CBER at 1-(800) 835-4709 or (301) 827-
1800; or by calling CDRH at 1-(800) 638-2041 or by faxing a request to 
CDRH at (301) 847-8149. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. 
Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori Jo Churchyard, 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 Elizabeth L. Frank, Center for Devices and 
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 1407, 
Silver Spring, MD 20993, (301) 796-5650.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Preparation of IDEs and INDs for Products 
Intended to Repair or Replace Knee Cartilage'' dated December 2011. The 
guidance document provides sponsors of an IDE or an IND recommendations 
about certain information that should be included in a submission 
describing a product intended to repair or replace knee cartilage. The 
guidance does not apply to prostheses such as unicondylar or total knee 
implants, or meniscus replacement products. Human cells, tissues, and 
cellular and tissue-based products (HCT/P's) regulated solely under 
section 361 of the Public Health Service Act (42 U.S.C. 264) and 21 CFR 
part 1271 are beyond the scope of this guidance. A product intended to 
repair or replace knee cartilage may include a biologic, device, or 
combination product (comprised of two or more different types of 
regulated constituents) whose components would individually be 
regulated by CBER and CDRH. The guidance addresses issues that may 
arise in the development of articular cartilage repair or replacement 
products. The guidance supplements other FDA publications on IDEs and 
INDs that may be relevant to development of these products.
    In the Federal Register of July 9, 2007 (72 FR 37245), FDA 
announced the availability of the draft guidance of the same title 
dated July 2007. FDA received numerous comments on the draft guidance, 
and those comments were considered as the guidance was finalized. In 
response to comments, changes incorporated in the guidance included 
adding new sections and clinical study schedules, elaborating on 
nonclinical data considerations, and updating the references. In 
addition, organizational and editorial changes were made to improve 
clarity. Some terminology was changed to harmonize terminology within 
the Agency and does not change the intent of the guidance. The guidance 
also reflects input received from the public and the Cellular, Tissue, 
and Gene Therapy Advisory Committee meeting held on May 15, 2009. The 
guidance announced in this notice finalizes the draft guidance dated 
July 2007.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    The 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 have been approved under 
OMB control number 0910-0014; and the collections of information in 21 
CFR part 812 have been approved under OMB control number 0910-0078.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or http://www.regulations.gov.

    Dated: January 11, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-828 Filed 1-17-12; 8:45 am]
BILLING CODE 4160-01-P