Congress and public interest groups have hammered the FDA’s scrutiny of postmarket surveillance and the agency has responded. Now, Medical Device Reporting (MDR) systems are often the first place the FDA targets during an inspection. Non-compliance is taken as an indication of a facility operating outside a state of control and a sign of larger problems to come.
The device and diagnostic industry has been caught unaware, and warning letters for insufficient MDR systems are on the rise. Just this year, a firm was warned for not reporting that its UV phototherapy systems were blamed for burning patients. Another was cited for not establishing quality system measures — it had no MDR procedures at all.
What can you do to avoid getting warning letters and the bad press that follows?
Attorney Pamela Furman will teach you about the MDR regulatory framework, the penalties of noncompliance, pitfalls to avoid and the significant keys to success.
Order today to listen in and discover:
Learn how to avoid warning letters and the negative press attention that follows.
Pamela Furman is a partner in King & Spalding's FDA/Healthcare Practice Group. She joined the firm in 2007, bringing with her more than 12 years of experience in advising clients on a broad range of FDA regulatory issues. Pamela’s practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, reclassification, import/export issues, and investigational device exemption (IDE) requirements.
Pamela graduated summa cum laude, Phi Beta Kappa, from Yale University in 1988 with a Bachelor of Arts in political science and received her law degree from Stanford University in 1994. She is an active member of the American Health Lawyers Association (AHLA) and currently serves on the editorial board of AHLA's Journal of Health and Life Sciences Law.
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