5.06. What FDA Requirements Apply to My Regulated Device?
This course has been prepared by Neil O’Flaherty who heads the Medical Device Practice Group at Amin Wasserman Gurnani LLP (www.awglaw.com). He assists clients with U.S. FDA premarket and post-market issues to ensure legal medical device product launches in the U.S. and continued compliance with applicable statutes and regulations once the products are on the market. He also assist clients with U.S. FDA medical device issues related to drafting and negotiating manufacturing, distribution, joint venture and other business agreements and conducting regulatory due diligence activities. Neil is a frequent speaker for industry conferences, seminars, and educational training programs.
- Medical device classification
- Class I devices
- Class II Devices
- Class III Devices
- De Novo Devices
- In Vitro Diagnostics
- Investigational Device Exemptions (Clinical Studies)
- Good Laboratory Practices
- Medical Device Tracking
- Postmarket Surveillance
- Recalls (Including Corrections and Removals)
- Overview of Medical Device Promotion and Marketing Considerations
- Import and Export of Devices
Course duration: 1 hr 30 min.
