The 21st Century Cures Act and its Effect on FDA’s Regulation of Devices and Combination Products
In this 90 minute webinar, participants will learn about the multiple provisions of the 21st Century Cures Act that affect the regulation of medical devices and combination products. Highlights will include the new exclusion of clinical decision support software from the definition of a “device”; Congress’s renewed emphasis on application of the least burdensome requirements to review of device submissions; changes in the requirements for humanitarian device exemptions; and new cleaning and validation requirements for reusable devices, which stem from the recent issues involving infected duodenoscopes. In addition, this webinar will cover the combination products provision, in which Congress has attempted to address FDA’s historical tendency to designate products as drugs.
Speakers for this webinar will be Jeffrey K. Shapiro and Allyson B. Mullen. After the presentation, participants will have an opportunity to ask questions.
Wednesday, January 18th
12:00 - 1:30 PM ET