Regulatory Briefs: FDA Meetings On Cancer Tests, Glaucoma Devices; DeLauro Questions Device Reclassifications
This article was originally published in The Gray Sheet
Executive Summary
An FDA advisory panel will discuss PMAs for two molecular diagnostics for colorectal cancer screening in March. A February workshop will address clinical trial design for minimally invasive glaucoma devices. Rep. DeLauro speaks out about FDA device reclassifications. More regulatory briefs.
You may also be interested in...
News Briefs: Teleflex Acquires Vidacare; Integra Buys Covidien’s DuraSeal Line
Teleflex buys Vidacare Corp. for $262.5 million. Integra LifeSciences acquires Covidien’s Confluent Surgical product line, including the DuraSeal products, for $235 million, plus up to $30 million in milestone payments. W.L. Gore ordered to pay more than $850 million to C.R. Bard to partially resolve a long-running patent dispute. More news.
FDA Calling For More PMAs Than 510(k)s In Final Set Of Preamendment Devices
“The Gray Sheet” reviewed CDRH’s proposed orders and final classification decisions on preamendment devices targeted by the 515 initiative. As of Aug. 5, FDA has proposed or finalized 14 PMAs, and proposed or finalized 10 products to be downclassified to class II with special controls.
Draft Guidance On PMA Annual Reports Focuses On Device Modifications
A draft guidance detailing what FDA expects manufacturers to include in annual reports for PMA-approved devices is less burdensome to industry than expected