The FDA Reauthorization Act of 2017 (FDARA), signed into law on August 18, 2017, amended several sections of the Federal Food, Drug, and Cosmetic Act. This document was developed and issued prior to the enactment of FDARA, and certain sections may no longer be current as a result. FDA is assessing how to revise this document to represent our current thinking on this topic. For more information please contact CDRH-FDARA@fda.hhs.gov.
This guidance is intended to assist device establishments in determining whether they are eligible to participate in the AP Program and, if so, how to submit notification of their intent to use such a program. Any establishment that is interested in obtaining additional information about eligibility or other matters addressed in this document should address the contacts listed on the cover of this guidance.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.