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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

The US Food and Drug Administration won’t require prior notification for some device modifications driven by the COVID-19 pandemic, the agency announced in a recent guidance document.

The guidance, which went into effect on 21 May, will remain active for the duration of the COVID-19 public health emergency. It applies to some changes to devices cleared via...

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