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When: 25 May 2021
Type: Webinar
Join Dykema for a complimentary webinar describing the FDA’s de novo classification option, its advantages, tips on how to complete the process to secure classification, and how to successfully navigate the intersection between FDA regulation and patent law.


Tuesday, May 25, 2021
1:00 - 2:00 PM CDT

The Intersection of Regulatory and Intellectual Property Issues in the Medical Device World

The de novo classification process for medical devices is little used, but potentially very helpful for companies with products that lack a suitable predicate device. Most medical devices are cleared through the FDA's 510(k) pathway, requiring a demonstration of substantial equivalence to a legally marketed predicate device. Patent protection, however, requires a medical device to be novel and non-obvious.

Mark Mansour, Member
Tania Sharpiro Barr, MD, Member

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