Guidance: FDA Won’t Ask For Notice On Some Device Mods Tied To COVID-19

 
• By Elizabeth Orr

Sponsors of PMA or HDE-authorized devices can make some modifications in response to COVID-19 without first alerting the US FDA under a recent guidance document.

MEDOLLA, ITALY-OCTOBER 17, 2012: Hands with gloves assembling a medical device on a factory line, at the Gambro factory, Italian division.
Some manufacturing changes for medical devices won't require FDA notice during the COVID-19 crisis under a new guidance document

More from Regulation

More from Policy & Regulation