510(K) EXEMPTION FOR 164 CLASS I, TIER I DEVICES PROPOSED BY FDA
This article was originally published in The Gray Sheet
Executive Summary
510(K) EXEMPTION FOR 164 CLASS I, TIER I DEVICES PROPOSED BY FDA in a July 21 Federal Register notice. The agency explains that the premarket notification requirements for the devices are "unnecessary" to protect the public health and says the exemptions "will allow the agency to make better use of its resources and thus better serve the public."