Regulatory Briefs: What's New From FDA
This article was originally published in The Gray Sheet
Medtronic gets February panel date for its DIAM spine device, which would be the firm's second interspinous spacer on the market; FDA moves risk classifications forward for five device types; and the agency continues its scrutiny of direct-to-consumer genetic tests.
You may also be interested in...
A new guidance document and final rule from US FDA on Bacillus bacteria detection devices, which are used to diagnose anthrax, place the pre-amendment devices in class II.
A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.
A majority of FDA advisors say the device intended to treat lumbar spinal stenosis has a positive risk-benefit profile but should require an extended postmarket trial to evaluate its safety and efficacy over a longer time period.