Several important pieces of FDA legislation have recently been passed that significantly affect the medical device industry. FDA has been busy implementing the new laws, issuing numerous final and draft guidances and policies.
These developments directly affect device companies:
- Implementing changes in device inspections to make them more risk-based
- Establishing pilots for the use of Real World Evidence
- Issuing new checklists for de novo submissions
- Evolving approaches for patient preference information
- Developing guidance in the digital health space
- Streamlining MDR reporting, and more
Keeping up with the array of changes and proposed changes is challenging. Join a panel of industry and agency experts for a status update on what’s happened already, what’s coming, and where medical device companies should be focusing their efforts.
Nathan Brown, Partner, Akin Gump Strauss Hauer & Feld LLP
Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Medtronic, and Member, FDLI Board of Directors
Aaron Josephson, Policy Advisor, CDRH, FDA
Moderated by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC, and Chair, FDLI Board of Directors