FDA’s “New” Guidance for Medical Device Meetings: Old Info in New Package 
[Thursday, May 9, 2019]

This week FDA released a “new” guidance about medical device meetings which is rehash of old advice with several tips to make these meetings productive. It can be argued that there are few, in any, new proposals in this guidance but it is still a useful read for the industry. FDA meetings are an excellent way to get direct feedback from the regulators for critical issues, but these meetings also require a significant commitment for the time from the reviewers. So, it is necessary for the FDA to define clear rules regarding these meetings. The guidance describes processes specific to meetings with CDRH, but many principles are identical to meetings with drug or biologics reviewers. The document describes six distinct categories of meetings from informational meetings where the FDA promises to primarily listen without a commitment for feedback to issue resolution meetings where FDA would give specific advice to address critical concerns during development of a new product. There are better descriptions of scenarios, even examples of how to ask questions and checklist to help sponsors appropriately label their meeting requests and get the most out of a meeting. This may be disappointing for those expected new concepts but are generally reassuring to those experienced in meeting FDA that the overall processes have not changed. This document is an excellent educational tool for almost all interested in meetings with the CDRH and may offer clues for productive meetings with other departments at FDA as well.