Q&A on Medical Device Reporting Requirements

September 24, 2013

Please join us for a one-hour webinar to discuss the FDA's new draft guidance on Medical Device Reporting (MDR) requirements as well as an interactive Q&A on everything you always wanted to ask about MDR.

Topics will include:

  • An overview of MDR requirements and the role of MDR in FDA's postmarket surveillance of devices
  • The differences between the recently issued draft guidance on MDR requirements and the FDA's 1997 guidance and the regulatory implications of those differences
  • Frequently cited MDR violations and errors
  • A Q&A opportunity to ask any questions you may have on MDR, such as when a malfunction is reportable, when a reporting is not required, how to complete the MedWatch Form, and how many reports to file
  • Questions that cannot be addressed due to time or other constraints will be answered via email.

Tuesday, September 24
12–1 pm ET

M. Elizabeth Bierman | Partner, Washington, D.C.
Michele L. Buenafe | Associate, Washington, D.C.

CLE Credit:
CLE credit in FL, IL, NJ, NY, PA, TX, and VA is currently pending approval.