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The FDA is considering a master file pilot program for premarket approval holders whose approved devices are sterilized using radiation, including gamma radiation.
On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities that meet the definition of remanufacturing and a process for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 ...