The widespread adoption of next-generation sequencing technology in molecular pathology has enabled us to interrogate the genome as never before. The huge quantities of data…
The FDA publishes decision summaries for most of the in vitro diagnostics (IVDs) that it reviews through its 510(k), De Novo, and PMA premarket review programs. When the…
This page lists medical devices that have FDA authorized Predetermined Change Control Plans (PCCPs) based on searches of device authorization letters and approval order…
In December 2022, the Food and Drug Omnibus Reform Act of 2022 provided the FDA with new authority related to the authorization of Predetermined Change Control Plans…
The FDA publishes quarterly and annual reports that include performance metrics for the medical device review process. These reports can include thousands of performance…