FDA plans pilot for third party review
This article was originally published in Clinica
Executive Summary
A pilot programme for third party review of selected 510(k) notifications is expected by the US FDA to get under way early in fiscal 1996. Part of the agency's policy reform package announced in April (see Clinica No 649, p 6), the pilot project will be restricted to third party review - but not clearance - of low-risk medical devices.