In Brief: Preamendment Class III device reg
This article was originally published in The Gray Sheet
Executive Summary
Preamendment Class III device reg: FDA publishes proposal June 18 to retain in Class III three preamendment Class III products -- lung water monitors, powered vaginal muscle stimulators for therapeutic use, and stair-climbing wheelchairs. Written comments are due Sept. 16. Summaries of and citations to safety and effectiveness data on the devices were due at FDA in August 1996. Based on "the lack of safety and effectiveness data submitted in response" to the call for data, FDA concludes that insufficient information exists to reclassify the products...