Food and Drug Administration (FDA) is the legal authority to establish rules and regulation for the use of medical devices within the United States. According to Food, Drug, and Cosmetic Act products falling within the scope of medical devices, shall be registered in FDA database. In that sense, FDA 510 K clearance is required for …
EMC of Medical Devices – 510 K Content For active medical devices, the EMC information is an important part of the 510 K file. Currently the required information is listed on the guidance document “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices” issued on July 2016. FDA issued recently a …
On August 5, 2020, the FDA issued an umbrella emergency use authorization (EUA) for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorizes the emergency use of surgical masks that meet certain performance requirements for use in healthcare settings by health care personnel …