The 510(k) Process - Webinar Recording/Transcript

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

As medical device software and other technology continue to advance at a rapid pace, the FDA’s regulatory policies and processes are being forced to evolve to keep pace with innovation.

FDAnews has enlisted attorneys Jennifer Nowark and Sara Klock of Holland and Knight to guide you through the whirlwind of regulatory change.  They’ll discuss the recent guidance (Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics) and to what extent technology will be regulated by the FDA. Over the course of 90 minutes, they’ll provide insight into what will be regulated as medical device technology and what may cause the technology to require premarket review.

You’ll learn about:

  • The agency’s groundbreaking pilot program that determines whether the clearance process can and should be updated
  • How the FDA’s recent final guidance affects regulatory specialists
  • How to identify factors that determine the extent certain new technologies are regulated as medical devices
  • How the FDA’s Expanded Abbreviated 510(k) program affects you
  • What characteristics may cause your technology to require premarket review
  • How the FDA is addressing potential vulnerabilities, such as cybersecurity risks

Order today to learn about the recent trends and initiatives affecting the 510(k) process as well as the evolving regulatory framework that may result in changes to the types of devices subject to 510(k) clearance.

  • Executive suite
  • Regulatory affairs
  • Compliance professionals
  • Medical professionals
  • QA/QR/QC
  • Legal counsel

Meet Your Presenters

Jennifer Nowak, JD, Holland & Knight,  Public Policy & Regulation Group
Ms. Nowak regularly advises pharmaceutical, medical device, biologic, dietary supplement, cosmetic and food distributors and manufacturers on pathways to market and pre-market requirements, labeling, advertising, clinical investigations, quality systems requirements and post-marketing requirements. She counsels clients through FDA inspections and post-inspection proceedings, and represents them before the FDA on enforcement and compliance issues, regulatory policy matters and during user fee negotiations.

Sara Klock, JD, Holland & Knight,  Public Policy & Regulation Group
Ms. Klock focuses her practice on food, drug and device, and life sciences law. She advises clients on regulatory matters before federal and state regulatory and law enforcement authorities, including the U.S. Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC). She also plays a key role in supporting and advancing client legislative and regulatory goals and initiatives.