FDA’s Plan for Modernizing the 510(k) Pathway - Webinar Recording/Transcript

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FDA’s Plan for Modernizing the 510(k) Pathway: What Regulatory, Quality & Compliance Professionals Need to Know

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.

Instead of basing substantial equivalence on older predicate devices, the FDA is looking for equivalence to a contemporary baseline of objective safety and performance criteria.

Mary Vater, medical device consultant at Medical Device Academy, Inc., will share best practices and tips for preparing and submitting 510(k)s. She’ll discuss common mistakes and the FDA’s current and evolving expectations for submissions. After 90-minutes you’ll know:

  • What specific changes the FDA has made to the 510(k) process — including the implications for companies who choose predicates cleared more than a decade ago
  • How to identify a suitable and favorable predicate device
  • What type of adverse events are common in your product classification
  • How to deal effectively with new challenges — including the possible need for additional testing to reflect post-market information for your device classification
  • How the FDA is addressing the changing biocompatibility requirements
  • How to overcome specific challenges companies face in creating and executing a sufficient test plan
  • The best time to file your pre-submission within the development process
  • The right questions to ask to gain the most value from your meeting

This presentation will break down the 510(k) process and let you know what changes you can anticipate for future submissions.

  • Regulatory affairs specialists
  • Medical device consultants
  • Biomedical engineers
  • Research and development engineers

Mary Vater, Medical Device Consultant, Medical Device Academy, Inc.
Mary Vater is an experienced Biomedical Engineer, now serving as a Medical Device Consultant with Medical Device Academy, Inc., specializing in Regulatory Affairs. Mary started her career at a medical device contract manufacturer, wearing several hats during her time in R&D, Engineering, and Quality Assurance. Mary now works on a QA/RA Consulting team called Medical Device Academy. In her first year of consulting, Mary received six 510(k) clearances for her client companies' products, working in the areas of reprocessed medical devices, surgical sutures, software-only medical devices, in vitro diagnostics, and orthopedic implants.