FDA PMA (PreMarket Approval)
- Speaker:Grace Powers
- Date: 18th March 2019 10:00 AM PST | 01:00 PM EST
- Product Code:GRC-90543
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This webinar will discuss all aspects of the US FDA PMA(Premarket approval) process. This webinar will review what types of products require a PMA. It will include a review of the types of PMAs- traditional and modular. Also, the content of a PMA will be discussed. The webinar will include an overview of the post-market submission requirements for PMAs such as 30-day notices, supplements, real time reviews, etc. This webinar will provide an overview of the entire PMA process.
- Understand the USA FDA PMA process
- Understand the types of PMA submissions
- Understand the types of Post-Market PMA submissions
- Understand the various types of FDA meetings
- Understand the logistics of an in-person FDA meeting
- PMA Annual Reports
- PMA 30-day change notices
- PMA Real Time Review
- PMA Supplements
Areas we will be discussing:
- What is a PMA?
- When is a PMA required for my product?
- What information is required in a PMA?
- Once my PMA is approved what types of product changes require additional approval?
Anyone from small or large companies looking to submit a Pre-Submission
- Compliance Officers
- Regulatory Affairs - all levels
- Clinical Affairs - all levels
- Quality Assurance - all levels
- Quality Engineering - all levels
- Medical Scientists
- R&D - all levels
- Anyone interested in the FDA PMA process
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 an 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.