USA – CDRH FY 2021 guidance slate includes post-EUA transition plan

Surgical staplers and laparoscopic power morcellators are among devices that made the grade for the US Food and Drug Administration’s (FDA’s) slate of final guidance topics for fiscal year 2021. The agency also plans to draft a transition plan for devices that have received emergency use authorizations (EUAs) during the pandemic.
 
The Center for Devices and Radiological Health (CDRH) at FDA released the list of draft and final guidance documents it plans to issue in fiscal year (FY) 2021 on 16 October, prioritizing its plans into an “A-list” of guidances it plans to publish and a “B-list” of documents it intends to publish “as resources permit” through the fiscal year.
 
In addition to guidances on surgical staplers and product labeling for laparoscopic power morcellators, other device guidance topics that made the A-list to finalize in FY 2021 include the Safer Technologies Program for medical devices, a voluntary program to improve the safety of some currently available device or device-led combination treatments or diagnostic products…