Are You a Medical Device Servicer or Remanufacturer? FDA’s New Guidance May Help…Or Not

On June 24, 2021, the Foodstuff and Drug Administration (Fda) issued the extended-awaited Remanufacturing of Healthcare Equipment Draft Advice (Draft Remanufacturing Advice), which describes the agency’s recent thinking on routines that fulfill the definition of remanufacturing and a approach for identifying whether an act performed to an initial products manufacturer’s (OEM’s) legally marketed completed unit is regarded remanufacturing….
By: Mintz – Health Care Viewpoints