Wednesday, December 9, 2009
1:00-2:30 pm Eastern (12:00-1:30 pm Central; 11:00 am-12:30 pm Mountain; 10:00-11:30 am Pacific; 9:00-10:30 am Alaska; 8:00-9:30 am Hawaii)
Co-sponsored by the Hospitals and Health Systems (HHS), In-House Counsel (In-House), Life Sciences (LS), and Teaching Hospitals and Academic Medical Centers (TH/AMC) Practice Groups
Description
Hospitals must source and use medical devices and drugs regulated by the U.S. Food and Drug Administration (FDA). However, if hospitals do not ask the right questions in sourcing them or before using them, or undertake other FDA-regulated activities involving them without proper controls, they can find themselves unknowingly in noncompliance with FDA requirements. Noncompliance can lead to enforcement action by the FDA, other legal exposures, and even unwanted publicity. As such, it is extremely important for hospitals, as well as their staff, to know and understand the FDA regulatory issues which surround sourcing and use of medical devices and drugs and to properly evaluate and implement other activities within their facilities which have FDA regulatory implications.
As part of this webinar, participants will learn about:
- Potential pitfalls in sourcing medical devices and drugs for use in a hospital and how to avoid them;
- The difference between commercial and investigational products and what questions to ask to determine their status;
- What questions to ask to determine whether or not a product is a custom medical device that does not need premarket approval or clearance from FDA before use;
- Hospital activities, and those of its staff, which do and do not trigger FDA regulation, including the practice of medicine and pharmacy, off-label use of products, reuse of single use medical devices, and remanufacturing versus servicing of medical devices; and
- The FDA regulatory implications of personal use of unapproved medical devices and drugs by patients while under a hospital’s care.
Presenters
- Naomi J. L. Halpern, Esquire
Partner
Frommer Lawrence & Haug LLP, Washington, DC
- Casper E. Uldriks, Esquire
Associate Director for Regulatory Guidance and Government Affairs
Office of the Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration, Rockville, MD
Moderator
Continuing Legal Education (CLE)
CLE information will be provided to registrants at the URL where you access the materials. Find out more information on CLEs for webinars.