Latest Breaking News On - Draft remanufacturing guidance - Page 1 : comparemela.com

On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities that meet the definition of remanufacturing and a process for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 solicit opinions on quality, safety, and continued effectiveness of medical devices that have been subject to refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing. Subsequently, the Food and Drug Administration Reauthorization Act of 2017 (FDARA) required FDA to publish a report on the continued quality, safety, and effectiveness of medical devices with respect

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