Medical Devices | 合法醫療器材資訊網

FDAregulatesthesaleofmedicaldeviceproductsintheU.S.andmonitorsthesafetyofallregulatedmedicalproducts.

The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023.

Existing emergency use authorizations (EUAs) for devices remain in effect, and the FDA may continue to issue new EUAs going forward while the EUA declarations under section 564 of the Federal Food, Drug, and Cosmetic Act are in effect and when the criteria for issuance of an EUA are met.