FDLI’s New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures

FDLI’s New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures

FDLI’s New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures

Posted: 07 Feb 2018 07:18 PM PST

By Hyman, Phelps & McNamara, P.C. —

On Friday, February 9, 2018, from 2:00-3:30 PM ET, the Food and Drug Law Institute (“FDLI”) will be hosting a webinar, titled “New Medical Device Requirements and Where Manufacturers Should Focus:  MDUFA, FDARA, and 21st Century Cures.” Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs will be moderating the webinar.

As the title of the webinar suggests, several important pieces of FDA legislation have recently been enacted that significantly affect the medical device industry.  FDA has been busy implementing the new laws, issuing numerous final and draft guidance documents and policies.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.

You can register here for the webinar.