Medical Device Reporting: Best Practices and Common Pitfalls – Webinar Recording/Transcript
Don’t let an FDA enforcement action be your lesson in understanding Part 803 and medical device reporting (MDR).
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, you cannot afford to miss this webinar.
FDA inspection metrics show that many still don’t understand — or can’t comply — with the regulations.
Pamela Forrest, a partner and co-chair of Covington & Burling’s medical devices and diagnostics practice, will share what you must do to build — or adapt — your MDR system to withstand FDA scrutiny.
In the past 10 years alone, about one in 10 devicemakers has been cited for lack of written MDR procedures. Many more were cited for failure to meet reporting deadlines, reporting inadequately…or not reporting at all. This webinar will help you avoid the same fate.
A 25-year veteran of FDA regulatory compliance, Ms. Forrest will break down the requirements, terms and timelines presented in Part 803, one of the thorniest areas of FDA regulation. She will also advise you of best MDR practices and explain how to avoid common pitfalls.
- 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 you’re less than confident your MDR system will prevent Part 803 enforcement actions, you need this presentation.
Meet Your Presenter
Pamela Forrest is a partner in Covington & Burling’s food, drug and device practice and co-chair of the firm’s medical devices and diagnostics practice. With more than 25 years of experience in advising clients on a broad range of FDA regulatory issues, her practice focuses on FDA medical device matters, including MDR, premarket notification, premarket approval, product recalls, quality system compliance, establishment registration and device listing, labeling and promotion, import/export issues, and clinical trial requirements.
Ms. Forrest has written and spoken extensively on various aspects of FDA regulation of medical devices and has testified before several state legislative committees regarding medical device legal and regulatory issues.
Who Will Benefit
- Regulatory/quality/compliance staff
- Legal staff, including liability specialists
- Field operations managers
- Anyone working for a devicemaker who might have contact with complaints or adverse events reported by device users (e.g., sales reps and field technicians)
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June 21, 2022