Zdrowie i gospodarka · 23/09/2024

FDA Announces Availability of Draft Guidance Documents for Accreditation Scheme for Conformity Assessment Program

The Food and Drug Administration (FDA) has released three draft guidance documents related to the Accreditation Scheme for Conformity Assessment Program, which aims to ensure the safety and efficacy of medical devices, in accordance with the FDA User Fee Reauthorization Act of 2022 and the Medical Device User Fee Amendments of 2022.