Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage Guidance for Industry December 2011
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
This guidance document provides to you, sponsors of an investigational device exemption application (IDE) or an investigational new drug application (IND), recommendations about certain information that should be included in a submission describing a product intended to repair or replace knee cartilage. For the purposes of this document, a product intended to repair or replace knee cartilage, as with other cartilage repair or replacement products,1 may include a biologic, device, or combination product2 whose components would individually be regulated by the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER).3,4 This guidance finalizes the draft guidance of the same title dated July 2007.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2007-D-0020.