Kathryn Burke, Emergo Group
The FDA has revised the guidance document Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions to update the considerations on identifying and responding to deficiencies in premarket submissions. The document supersedes the one of the same title issued on Nov. 2, 2000.
The revised document further clarifies the content and format of a deficiency letter and includes a new list of examples of deficiencies and applicant responses.Guidance on requesting additional information for market registration
The FDA has finalized the guidance document to help agency staff develop requests for additional information needed to make a decision on a medical device marketing application. Requests for additional information for medical device marketing applications are known as deficiencies. The guidance also recommends the most efficient formats for agency and industry to send or reply to such deficienc…