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FDA UpdatesNew Requirements, Trends and Guidelines
Stay current on the ever-changing medical device regulatory environment with this 2 half days course offering practical guidance on navigating recent changes in FDA requirements, trends and guidelines. This course offers participants updates on a variety of topics like
- Emergency Use Authorization (EUA)
- Medical Device Development Tools (MDDT)
- CDRH's Innovation Initiative
- Digital Health
- CDRH’s Strategic Prioritie
- Technical Amendments to...Continue reading
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Issues to be covered
- Updates on legislation affecting medical devices
- Recent FDA initiatives related to medical devices
- Trends in FDA activities related to medical devices
- New guidance documents affecting medical devices
Who should attend
This course is intended for individuals with responsibility for FDA regulatory affairs in medical device companies that are interested in updating their knowledge.
Benefits to the Participants
Participants in this course will:
- Get an overview of changes in FDA jurisdiction over medical devices
- Gain understanding of trends in FDA regulatory framework of medical devices
- Strengthen knowledge of FDA requirements
- Study from experience of others by learning and discussing case studies
- Have an opportunity to share their regulatory challenges and experiences with colleagues
About The Lecturer
Shoshana Friedman
Shoshana (Shosh) Friedman is Founder and Managing Director of ProMedoss,
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