Class Act: Status Of CDRH’s 515 Initiative
This article was originally published in The Gray Sheet
Chart updating FDA’s progress and decisions in classifying the final set of preamendment devices.
You may also be interested in...
External pacemaker pulse generators and pacing system analyzers would move from class III to class II with special controls in a Sept. 15 proposed order. For most of the products, the 510(k) route would be maintained, but triple-chamber PSAs would move from PMA to 510(k) review under the proposal. .
News Briefs: Medtronic’s CoreValve Approval; J&J Dx Unit Set For Sale; Google’s Glucometer Contact Lens
Medtronic gains FDA approval for its transcather CoreValve system months earlier than predicted. The Carlyle Group makes binding offer for J&J’s Ortho-Clinical Diagnostics business. Google is developing a wireless glucometer embedded within a contact lens. More news briefs.
The Circulatory System Devices Panel supported class II, with special controls, reclassification proposals from FDA for extracorporeal membrane oxygenators; external cardiac compressors; and external pacemaker pulse generators and triple chamber pacing system analyzers. But the panel had some additional requests for further action by the agency.