Grace Powers is an independent regulatory affairs consultant. She founded Powers Regulatory Consulting in 2015 to help clients with regulatory strategies and submissions. Her clients have included universities, investors, start-ups, and mid-size medical device companies. She has fifteen years of industry experience in medical devices including research and development. She has previously worked at Brookhaven Medical, Bard Medical, CardioMEMS, and Novoste, all in the Atlanta area. She has leadership experience with managing regulatory affairs responsibilities related to all pre and post-marketing regulatory activities and submissions. Her RA submission experience includes 510(k), Pre-Submissions, IDE, PMA, EU Technical Files, and Design Dossiers. She has also managed an International RA team which including Canadian licensing, TGA, Japan, China, Russia, Latin America, and other country submissions. Grace holds a BE in Biomedical Engineering from Vanderbilt University, an MS in Biomedical Engineering from UCLA, and an MBA from Georgia Tech. She is RAC US, RAC Europe, and RAC Global certified.
This webinar will discuss all aspects of the US FDA Pre-Submission process. This webinar will review when a Pre-submission may be appropriate for a company or product. It will include a review of the guidance document. The types of Pre-submissions will also be reviewed including those for IDE applications, study risk determinations, Pre-Sub for a 510(k), Pre-Sub for a PMA and Pre-Sub for an IVD. The content..