U.S. regulators to overhaul third-party 510(k) review program

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has set a goal of obviating the need to re-review 85% or more of 510(k) applications that have undergone third-party review by the agency’s 2021 fiscal year. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post U.S. regulators to overhaul third-party 510(k) review program appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Emergo Group Source Type: news