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Manufacturing Site Change Supplements: Content and Submission Guidance for Industry and Food and Drug Administration Staff December 2018


Manufacturing Site Change Supplements: Content and Submission

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance explains FDA’s current thinking regarding the following:

  1. What constitutes a manufacturing site change and when you should submit a PMA supplement for a site change;
  2. What documentation you should submit in a site change supplement; and
  3. The general factors FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement.

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 guidance means that something is suggested or recommended, but not required.

Submit Comments

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:

Division of Dockets Management (HFA- 305)
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.