Medical Devices Act

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

Authorized the FDA to ban devices 1977: The Bureau of Medical Devices and Diagnostic Products was renamed the Bureau of Medical Devices 1990: Safe Medical Devices Act (SMDA) Improved...

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 …

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 …

Medical Device Regulation Act - Wikipedia

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

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Introduction Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas …

Overview of the Safe Medical Devices Act of 1990

https://www.drugwatch.com/fda/safe-medical-device-act/

Medical devices, as regulated by the FDA, were originally defined in the FD&C Act as: “Any instrument, machine, contrivance, implant, in vitro reagent that's …

Safe Medical Device Act Definition | Arena

https://www.arenasolutions.com/resources/glossary/safe-medical-device-act/

The Safe Medical Devices Act (SMDA) of 1990 is a federal law that requires medical device manufacturers and user facilities (i.e., hospitals and ambulatory surgical facilities) …

H.R.3095 - Safe Medical Devices Act of 1990 - Congress

https://www.congress.gov/bill/101st-congress/house-bill/3095

Allows the Secretary to grant an exemption from certain effectiveness requirements for a device for which the Secretary finds that: (1) it is designed to treat or diagnose a …

Medical Device Nonvisual Accessibility Act Legislative …

https://acb.org/medical-device-accessibility-imperative

In 2021, Rep. Jan Schakowsky (D-IL) introduced the Medical Device Nonvisual Accessibility Act (H.R. 4853) in the House of Representatives. The goal of this act was to make home …

Medicines and Medical Devices Act 2021

https://www.legislation.gov.uk/ukpga/2021/3/contents/enacted

PART 4 Medical devices. CHAPTER 1 Regulations: general. 15. Power to make regulations about medical devices. 16. Manufacture, marketing and supply. 17. Fees, …