FDAnews Announces — FDA’s Plan for Modernizing the 510(k) Pathway: What Regulatory, Quality & Compliance Professionals Need to Know Webinar, Feb. 20, 2019

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Know the 510(k) process? Think again. The process as it is known is changing. Find out more now…

WCG Market Intelligence & Insights

WCG Market Intelligence & Insights

FDA’s Plan for Modernizing the 510(k) Pathway
**An FDAnews Webinar**
Wednesday, Feb. 20, 2019, 1:30 p.m. - 3:00 p.m. EST
http://www.fdanews.com/planmodernizing510kpathway

It’s becoming increasingly difficult to obtain 510(k) clearances on medical devices.

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 attendees will 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 product classifications
  • How to deal effectively with new challenges — including the possible need for additional testing to reflect post-market information for 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 pre-submission within the development process
  • The right questions to ask to gain the most value from the meeting

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

Meet Your Presenter:
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.

Who Will Benefit:

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

Webinar Details:
FDA’s Plan for Modernizing the 510(k) Pathway
What Regulatory, Quality & Compliance Professionals Need to Know
**An FDAnews Webinar**
Wednesday, Feb. 20, 2019, 1:30 p.m. - 3:00 p.m. EST
http://www.fdanews.com/planmodernizing510kpathway

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/planmodernizing510kpathway
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDAnews
703-538-7600
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