The Pre-Submission is becoming an increasingly popular means to approach the FDA for assistance with various questions which a potential 510k, IDE or PMA submitter may have. In this more informal setting, the FDA has greater flexibility in answering your questions.
Most testing performed for the 510(k) submission is based on FDA recognized standards. What do you do if the protocols for your test or study is outside of FDA’s recognized standard?
Smith Associates will submit a Pre-Submission to the FDA, for a modest fee, to seek FDA’s input concerning your protocol or other questions you may have concerning your upcoming 510(k)/PMA submission.
Bench Test Protocols
Required testing clarification
Draft clinical or draft Human Factor studies, etc.
The Pre-Submission review is non-binding for both parties but will provide you with sufficient information to make an informed business decision concerning your route to approval, and may save your company’s investing capital from being spent on incorrect testing or clinical studies with less than beneficial outcomes.