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

May 25, 2021

Medical Device Banner

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.
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 P.M. – 2:00 P.M. CDT

Speakers: Mark Mansour, Member and Tania Shapiro Barr, MD, Member

CLE accreditation is anticipated for California, Illinois and Texas. We provide Uniform Certificates of Attendance and jurisdiction-specific information for those licensed in other jurisdictions. HRCI eligibility will be determined after the program. If HRCI accredited, we provide Certificates of Attendance to all attendees who return a completed Record of Attendance. Please contact Amy Trevino at with questions.

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