FDAnews Announces: Medical Device Reporting, Best Practices and Common Pitfalls Webinar on June 21, 2022

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FDAnews

Jun 07, 2022, 00:00 ET

Avoid common medical device reporting mistakes, and FDA enforcement action, when implementing these best practices.

FALLS CHURCH, Va., June 7, 2022 /PRNewswire-PRWeb/ -- Medical Device Reporting
Best Practices and Common Pitfalls
An FDAnews Webinar
Tuesday, June 21, 2022, 1:30 p.m.–3:00 p.m. EDT
https://wcg.swoogo.com/medical-device-reporting

A medical device reporting (MDR) system could be all that stands between device professionals and Part 803 enforcement action.

A devicemaker's MDR system is one of the main areas of focus during an FDA inspection. And with Part 803 being one of the least understood regulations, devicemakers cannot afford to miss this webinar.

Pamela Forrest, a partner and co-chair of Covington & Burling's medical devices and diagnostics practice, will share what attendees must do to build, or adapt, their MDR system to withstand FDA scrutiny.

A 25-year veteran of FDA regulatory compliance, she will break down the requirements, terms and timelines presented in Part 803, one of the thorniest areas of FDA regulation. Ms. Forrest will also advise attendees of the best MDR practices and explain how to avoid common pitfalls, including:

  • The meaning of key MDR regulatory terms and concepts, including "malfunction," "become aware" and "caused or contributed"
  • Deadlines for submitting MDRs and the types of reports to file
  • What information must be included in an MDR
  • How to document and justify a decision NOT to file an MDR
  • The potential legal consequences of failing to comply with Part 803 requirements
  • Examples of FDA enforcement against firms for failure to comply with MDR requirements

If devicemakers are less than confident if their MDR system is working to prevent Part 803 enforcement actions, they need this webinar.
Webinar Details
Medical Device Reporting
Best Practices and Common Pitfalls
An FDAnews Webinar
Tuesday, June 21, 2022, 1:30 p.m.–3:00 p.m. EDT
https://wcg.swoogo.com/medical-device-reporting

Tuition:
$287

Easy Ways to Order:
Online: https://wcg.swoogo.com/medical-device-reporting
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.

Media Contact

Michelle Butler, FDAnews, 703-538-7665, [email protected]

SOURCE FDAnews