RAPS.org Article Published by Pearl Employee

Pearl Pathways is proud of employee Heidi Strunk, as she earned a publication in the RAPS online journal Regulatory Focus.  The full article can be found on RAPS.org (Login and Password required) and is entitled “Types of In Vitro Diagnostics: Clearing Up the...

New FDA Approach to Medical Device Accessory Regulation

FDA has released a draft guidance on its new approach for defining and classifying new medical device accessory types. Device accessories have previously been classified in congruence with the parent device or as a completely separate classification regulation. The...