Medical Devices Legislation

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Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Manufacturers must list their devices with the FDA. Establishments required to list their devices include: manufacturers, contract manufacturers, contract sterilizers, repackagers and...

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …

A History of Medical Device Regulation and Oversight in …

https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states

A History of Medical Device Regulation & Oversight in the United States The Food and Drug Administration (FDA) is the oldest comprehensive consumer protection agency in …

S.4336 - Strengthening Cybersecurity for Medical …

https://www.congress.gov/bill/117th-congress/senate-bill/4336/text?s=1&r=84

(a) In general.—Not later than 2 years after the date of enactment of this Act, and every 2 years thereafter, the Secretary of Health and Human Services (referred …

Overview of Regulatory Requirements: Medical Devices

https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript

It basically says a medical device is “any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate, diagnose disease in man”. Some …

Medical Device Safety | FDA

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

Jan 25, 2023

Medical Device Repair Act: the Right to …

https://intermed1.com/medical-device-right-to-repair-act/

The Alliance for Quality Medical Device Servicing (Alliance), a coalition of six of the country’s largest independent service organizations (ISOs), is strongly supportive of the Medical …

Medical Device Regulation Act - Wikipedia

https://en.wikipedia.org/wiki/Medical_Device_Regulation_Act

Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment of human health, or presents a potential …

Legislative changes in the field of medical devices

https://www.havelpartners.cz/en/legislative-changes-in-the-field-of-medical-devices/

In December 2022 and January 2023, new legislation on medical devices and in vitro diagnostic medical devices (jointly “ medical devices ”) came into force: an amendment …

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