
(AGENPARL) – SILVER SPRING ven 24 marzo 2023 This policy allows certain modifications to the design and manufacturing of previously approved PMA and HDE devices during the COVID-19 pandemic.
Fonte/Source: http://www.fda.gov/regulatory-information/search-fda-guidance-documents/supplements-approved-premarket-approval-pma-or-humanitarian-device-exemption-hde-submissions-during