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GUIDANCE DOCUMENT

Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions Guidance for Industry and Food and Drug Administration Staff September 2017

Final
Docket Number:
FDA-2017-D-5711
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document is intended to help Food and Drug Administration (FDA) staff develop a request for additional information needed to make a decision on a medical device marketing application in accordance with the Least Burdensome Provisions of the Food, Drug, and Cosmetic Act (FD&C Act). Such an FDA request for additional information is known as a “deficiency.” In addition, this guidance describes suggested formats for FDA staff to communicate deficiencies, and for industry to use for responses to such requests, in order to make efficient use of industry and FDA’s time. This guidance includes examples of well-constructed deficiencies and industry responses to facilitate an efficient review process. This guidance also details supervisory review, major/minor deficiencies, additional considerations, and prioritization of deficiencies in FDA deficiency letters.


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:

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-2017-D-5711.