How to Prepare for FDA Submissions and Communicate Them With the FDA

A medical device company making a submission to the FDA on any of these: INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, and Post-Approval Supplements; needs practice and learning of all the intricate aspects of these activities. The FDA approval is necessary to start legal manufacturing a medical device or a combination product in the US. The FDA drug and device approval system is complex, and this understanding needs to be there on the part of the submitting company. 

Of equal importance as the submission is how to communicate with the FDA about these at various stages before, during and after the submission. It calls for a thorough understanding of the regulations in all their detail. This complete understanding is necessary to sail through the filing process. Companies making the filing need to have an effective submission strategy, failing which they could invite enforcement actions from the FDA, not to speak of the waste of resources and time.

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