U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. FDA Decisions for Investigational Device Exemption Clinical Investigations
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

FDA Decisions for Investigational Device Exemption Clinical Investigations Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff August 2014

Download the Final Guidance Document
Final
Docket Number:
FDA-2011-D-0790
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA seeks to encourage medical device research and innovation to address important clinical needs and improve patient care. In many cases, device development and evaluation include clinical investigation. This guidance document has been developed to facilitate the initiation of clinical investigations to evaluate medical devices under FDA’s Investigational Device Exemptions (IDE) regulations, Title 21 Code of Federal Regulations (CFR) Part 812.

Submit Comments

Submit Comments Online

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:

Dockets Management
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-2011-D-0790.

Back to Top