Dr. Margaret Hamburg

Devices & Diagnostics

Will FDA step in with lab development tests?

In her speech at Advamed 2013, FDA Commissioner Dr. Margaret Hamburg said a new challenge will be regulating in some way lab development tests. Now, LDTs are left to CLIA, which, Hamburg said, does not ensure they are properly designed, consistently assembled or clinically valid. She called for a “critical baseline” of these sorts of in […]

Devices & Diagnostics

Minnesota senators recruit buddies to pressure FDA over 510(k)

Minnesota Sens. Amy Klobuchar and Al Franken along with Rep. Erik Paulsen have championed the medical device industry, giving speech after speech and writing letter after letter to the Food and Drug Administration about upcoming changes to its 510(k) approval program. I doubted the campaign would do much. But Wednesday, a bipartisan group of 15 senators sent a letter to FDA Commissioner Dr. Margaret Hamburg urging her agency, among other things, to adopt a more deliberate, cautious approach to amending 510(k).

News

Klobuchar, Paulsen urge FDA not to quash Minnesota device industry

Minnesota’s medical device community has enlisted some big guns to lobby the Food and Drug Administration against proposed changes that the industry says will hurt innovation and the state’s economy: United States Sen. Amy Klobuchar and Congressman Erik Paulsen. In a letter to FDA Commissioner Dr. Margaret Hamburg, Klobuchar, chair of the Senate Commerce Subcommittee […]