The FDA has updated its final guidance: “Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions.”
The new guidance, which supersedes “Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions” issued in 2017, is intended to help FDA staff develop—and industry respond to—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 Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA notes that the updates to the 2017 version were made “to clarify what constitutes a statement of the basis for the deficiency” consistent with commitments as outlined in the Medical Device User Fee Amendments of Fiscal Years 2023 Through Fiscal Year 2027 Commitment Letter. In addition, the guidance describes suggested formats for FDA staff to communicate deficiencies, and for industry to use for responses to such requests, in order to make more efficient use of industry and FDA’s time.
The guidance includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process. It also details supervisory review, major/minor deficiencies, additional considerations and prioritization of deficiencies in FDA deficiency letters.
Download the updated guidance here.
Related Articles
-
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
-
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
-
Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.
-
The FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022.
