510(k) third-party review program
This article was originally published in The Gray Sheet
Executive SummaryFDA expects to receive 140 premarket notifications annually from outside reviewers under the "Accredited Persons" program mandated to begin Nov. 21 by the FDA Modernization Act, the agency says in an Oct. 30 Federal Register notice. FDA anticipates accrediting 35 third parties, each of which is expected to process four 510(k)s a year. Since the inception of its third-party review pilot in August 1996, FDA has received thirty-two 510(k)s, agency staffers say
You may also be interested in...
The first vaccine for the new coronavirus has entered the clinic, with US firm Moderna leading the race.
Korean vaccine specialist SK Bioscience moves to develop versatile platform technology to deal with outbreaks of infectious diseases such as the new coronavirus, as the number of infections in the country surges.
Israel-based Binah.ai hopes to earn regulatory approval for a video-based monitoring app that can detect vital signs in minutes. See what Binah.ai's co-founder and CEO, David Maman, said about the technology here.