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USFDA Guidance: Developing & Responding to Deficiencies - Least Burdensome Provisions

Earlier today (28-October-2022) the USFDA released final guidance on "Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions".

In some instances, FDA’s requests for additional information needed to complete the review process are colloquially known as “deficiencies.” FDA may convey deficiencies via interactive review or through a deficiency letter.

The purpose of this guidance is to assist FDA staff in developing a request for additional information necessary to make a decision regarding medical device marketing applications in accordance with the Food, Drug, and Cosmetic Act's least burdensome provisions.

This guidance outlines suggested formats for FDA staff to communicate deficiencies, as well as for the industry to respond to these requests in order to maximize efficiency, and also details about the supervisory review, major/minor deficiencies, additional considerations, and prioritization of deficiencies in FDA deficiency letters.

The Least Burdensome Provisions are detailed in the FDA guidance document “The Least Burdensome Provisions: Concept and Principles".

Click this LINK to know more about the Table of Contents the Guiding principles, content, and format for deficiencies, Review of deficiency letters, and the suggested format for industry responses to FDA deficiencies.


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