Responding to Deficiencies During FDA Premarket Submission Review
The majority is medical device companies that submit Food and Drug Administration (FDA) submissions, including 510(k)s and premarket approval (PMA) applications, receive deficiency letters requesting additional information in order for the FDA to reach a decision to allow a device to be sold in the US.
Navigating through the FDA submission review process can be challenging, time-consuming and labour and resource-intensive.
NSF International provides medical device consulting services through the FDA premarket review process, including regulatory strategy, support with submission issues meetings, and the development of deficiency responses.
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