Mark Mansour, Partner, Bryan Cave, LLP
Some Concerned that New FDA Chief Counsel Lacks Food, Drug Law Experience
Although many stakeholders praised the selection of Maryland’s insurance chief to serve as the FDA’s top lawyer, some have expressed concern that he lacks experience with food and drug law. Still, many see his litigation background as beneficial and complementary to the FDA’s increased emphasis on enforcement.
FDA May Revise Guidance on Medical Device Approvals
The FDA has indicated that it may review its current guidelines on medical device approval and may issue a revised guidance that would require medical device manufacturers to notify the agency of any alterations to approved products. The change would occur as part of a larger agency review under Commissioner Margaret Hamburg and her chief deputy, Joshua Sharfstein.
CDRH Officials to Make 501(k) Process More Predictable
Officials at CDRH have stated that they want to break from what they acknowledge are questionable prior decisions and make the 501(k) process more predictable but are warning that this may mean that companies will need to be wary of relying primarily on past 501(k) clearance requirements or determinations.
FDA Announces Meeting to Identify Strategies for CDRH
The FDA is announcing a public meeting entitled: “Incorporation of New Science Into Regulatory Decisionmaking Within the Center for Devices and Radiological Health.” The purpose of the public meeting is to identify strategies and means for incorporating new science into the regulatory decisionmaking process within the agency’s Center for Devices and Radiological Health (CDRH). The meeting will be held on February 9, 2010, from 8 a.m. to 5 p.m. in Gaithersburg, Maryland. More information is available here.
Mark Mansour is a partner in the firm, Bryan Cave, LLP
