Manufacturing Site Change Supplements: Content and Submission Guidance for Industry and Food and Drug Administration Staff December 2018
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological Health
This guidance explains FDA’s current thinking regarding the following:
(A) What constitutes a manufacturing site change and when you should submit a PMA supplement for a site change;
(B) What documentation you should submit in a site change supplement; and
(C) The general factors FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement.
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-2015-N-3454.