In Case You Missed It: Top 10 Gray Sheet Stories In March
This article was originally published in The Gray Sheet
A story covering the latest details on FDA's Office of Regulatory Affairs wholesale restructuring was the most popular Gray Sheet item last month, followed by a piece with tips on regaining FDA's trust. There was also significant interest in our coverage of the closely watched Vascular Solutions off-label case, challenges for notified bodies in Europe, Senate action, user-fee negotiations, and more.
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Shuren In The Lion’s Den: Device Center Chief Defends LDT Plan At Clinical Lab Meeting, Fields Wide Array Of Questions
FDA device center Director Jeff Shuren explained and defended fine points of FDA’s proposed laboratory-developed test framework before some of his sharpest critics: members of the American Clinical Laboratory Association, who face an entirely new regulatory scheme once the LDT proposal is finalized.
The Senate HELP Committee voted March 9 in favor of a breakthrough device provision, watered down from a version approved in the House last year. Other bills voted out of committee include a combination products reform measure, the digital-health focused MEDTECH Act, and four others. Senators are still debating whether NIH and FDA should get additional funds to cover the cost of the bills, which will be wrapped up into a broader package before Senate floor debate.
The case against the venous device manufacturer turned on the rights of manufacturers to use truthful off-label speech to promote their products. It joins a growing body of cases in which courts have sanctioned broader off-label speech than has traditionally been allowed by FDA.