Proposed 510(k) exemption for 18 devices expected in first half of 1997.
This article was originally published in The Gray Sheet
Executive Summary
PROPOSED 510(k) EXEMPTION FOR 18 DEVICES EXPECTED TO INCLUDE 12 physical medicine products, FDAers say. The agency is planning to publish the proposed rule in the Federal Register in the first half of 1997, according to agency staffers. The list of devices will include some Class I and some Class II devices, which would be downclassified in order to be exempted from 510(k) requirements.