There are a number of pre-submission meetings and review procedures available to the device industry seeking advice from FDA during the developmental stages of IDEs, 510(k)s and PMAs. PDG can help maximize the value of your interactions with CDRH through the 510(k) Pre-Submission Program, pre-IDE Informational Meetings, Study Risk Determinations, Formal Early Collaboration Meetings, Submission Issue Meetings and PMA Day 100 Meetings.
Originally known as the pre-IDE program, pre-submission requests for information, teleconferences and face-to-face meetings with CDRH have evolved to include feedback on a variety of submissions. Now known as the Pre-Submission (Pre-Sub) program, the information derived from pre-subs is critically important, especially if the device involves novel technology, new indication or does not clearly fit a regulatory pathway. The optimal time to engage a consultant such as PDG is in advance of your pre-sub or formal meeting with CDRH.