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FDA guidance to help current manufacturing limitations due to disruptions caused by the COVID-19 – FDA to temporarily accept changes to devices approved through PMA or HDE.

BySylvie

For the duration of the public health emergency, FDA does not intend to object to limited modifications to the manufacturing of devices approved through the PMA program or the HDE program, without prior submission of the required PMA or HDE supplement or 30-day notice, where the modification does not create an undue risk in light of the public health emergency, and is necessary to address current manufacturing limitations or supply chain issues due to COVID-19-related disruptions.

See full guidance https://www.fda.gov/media/138265/download

See FDA Webpage https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supplements-approved-premarket-approval-pma-or-humanitarian-device-exemption-hde-submissions-during

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