Early Preparation, Now More than Ever, Is Key to Successful FDA Device Panel Meetings
This article highlights the importance of early preparation for Medical Device Advisory Committee meetings based on changes in FDA guidance.
Sponsors need to understand changes in the FDA’s Draft Guidance for Medical Devices Advisory Committees, and its implications, to better prepare for product approval. This article discusses how sponsors can anticipate likely panel issues well before Premarket Approval (PMA) submission, and proactively engage with the FDA early and consistently throughout the development program.
This article was originally published in The Gray Sheet. For the full article, please complete the form.