January 2018

The Do’s and Don’ts of Responding to Deficiencies During FDA Premarket Submission Review

The majority of medical device companies that submit FDA premarket submissions, including 510(k)s and premarket approval (PMA) applications, receive deficiency letters requesting additional information in order for FDA to reach a decision to allow a device to be sold in the United States. Navigating through the FDA submission review process can be challenging, time-consuming, and labor- and resource-intensive.

The following do’s and don’ts serve as a starting point to help navigate the medical device submission review process more effectively and efficiently.