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Mitigation of Cybersecurity Risks in Medical Device Software: FDA Discussion & Insights for OEMs, Remanufacturers, and Servicers | Goodwin

Mitigation of Cybersecurity Risks in Medical Device Software: FDA Discussion & Insights for OEMs, Remanufacturers, and Servicers | Goodwin
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Are You A Medical Device Servicer Or Remanufacturer? FDA's New Guidance May Help…Or Not - Food, Drugs, Healthcare, Life Sciences

Are You A Medical Device Servicer Or Remanufacturer? FDA's New Guidance May Help…Or Not - Food, Drugs, Healthcare, Life Sciences
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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Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities that meet the definition of remanufacturing and a process for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 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 ....

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Discussing FDA's Remanufacturing of Medical Devices Draft Guidance

Discussing FDA's Remanufacturing of Medical Devices Draft Guidance
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