Are You a Medical Device Servicer or Remanufacturer? FDA's New Guidance May Help…Or Not | Mintz - Health Care Viewpoints
On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities that meet the definition of remanufacturing and a process for determining whether an act done to an original equipment manufacturer’s (OEM’s) legally marketed finished device is considered remanufacturing. The Draft Remanufacturing Guidance is the culmination of a process that began in 2016, when FDA opened a docket for public comment and held a public workshop to ...
Source: jdsupra.com