The 510(k) Process: A Whirlwind of Change, Challenges, and Opportunities

Associates Jennifer Nowak and Sara Klock will be co-hosting an FDANews webinar where they will discuss the recent guidance, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications, and the extent technology will be regulated by the FDA. Ms. Nowak and Ms. Klock will also provide their insights into what will be regulated as medical device technology and what they may cause the technology to require premarket review.