On the heels of the release of the highly anticipated Institute of Medicine (IOM) report, Public Health Effectiveness of the FDA 510(k) Clearance Process, The Food and Drug Law Institute (FDLI) is holding a "Dialogue" on the report August 4 in Washington, D.C.
The half-day meeting, called "An FDLI Dialogue: A First Look at the IOM Study of the 510(k) Clearance Process," will take place at the Madison Hotel from 8:30 a.m. until 12:30 p.m.
The IOM report discusses components of FDA's review and clearance process for medical devices and whether it is effectively protecting patients.
FDLI, founded in 1949, is a non-profit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction. FDLI's scope includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco.
At the Dialogue, attendees will hear from Dr. William Maisel (Deputy Director for Science in the Office of the Center Director at CDRH, FDA), IOM committee members, device industry experts and other interested stakeholders. Attendees will be able to share perspectives on the possible short and long-term consequences the report might have on the medical device review process.
The conference is intended for experienced professionals in the medical device arena, including industry representatives, venture capitalists, academics, and legal and regulatory affairs experts.
The meeting is open to both FDLI members and non-members, and participation is in person or via teleconference.
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