Contains Nonbinding Recommendations
FDA and Industry Procedures for
Section 513(g) Requests for
Information under the Federal Food,
Drug, and Cosmetic Act
Guidance for Industry and
Food and Drug Administration Staff
Document issued on April 6, 2012
The draft of this document was issued on April 29, 2010
This guidance was updated on December 21, 2015 to correct addresses in
An agency may not conduct or sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number. The OMB control
number for this information collection is 0910-0705 (expires 5-31-2018).
See additional PRA statement in Section IX of the guidance.
For questions for the Center for Devices and Radiological Health regarding this document contact
the Premarket Notification (510(k)) Section at 301-796-5640.
For questions for the Center for Biologics Evaluation and Research regarding this document
contact the Office of Communication, Outreach and Development at 1-800-835-4709 or 301-827-
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health