How to Make Pre-Sub Program Communication With the FDA More Transparent

Are you getting closer to submitting a medical device for successful market clearance to the U.S. Food and Drug Administration (FDA)? Communication is the essence of all regulatory challenges associated with the mire of detail and information that is required for an approved clearance for a 510(k), Investigational Device Exemption (IDE), Premarket Approval (PMA), Humanitarian Device Exemption (HDE), Investigation New Drug (IND) or Biologics License Application (BLA). So, how can transparency help?

Use transparency to create a venue for a “pre-sub” review for submission. That’s what the FDA’s Center for Devices and Radiological Health (CDRH) did in September of 2017. Submission roundtables can now be scheduled that allow a company to discuss achieving results with the right data and the right orientation of that data to the FDA. 

• Recommendations for nonclinical or clinical studies not addressed by a guidance document.
• Requests to use an alternative means to address recommendations specified in a guidance document.

Email [email protected] to receive a hard copy of the guidance, document number 1677

It’s important to note that many other ways of communicating with the FDA are clarified in this document that are and aren’t pre-submission predicated for discussion. One example of a meeting not in the pre-sub category is, “meetings or teleconferences requested by either the applicant or FDA to discuss FDA requests for additional information for a marketing application under review or on hold (RTA) (See Section III.E Submission Issue Meetings).