Act On Medical Devices

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)...

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 | FDA Medical Device Safety The FDA monitors reports …

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

Medical Device Regulation Act - Wikipedia

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

New Medical ‘Right To Repair’ Legislation Endangers …

https://www.forbes.com/sites/sallypipes/2021/05/10/new-right-to-repair-legislation-endangers-california-patients/

The bill, along with similar versions that have been introduced this legislative session in a handful of states including Texas, Arkansas, and Hawaii, (the latter two have already failed to pass...

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 …

Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

Additionally, the Federal Food, Drug, and Cosmetic Act (the Act) provides a means for obtaining the FDA’s views about the classification and the regulatory requirements that …

Legislation and Guidelines - Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/legislation-guidelines.html

The Therapeutic Products Directorate (TPD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to …

New Polish Act on medical devices - Part Three - Taylor …

https://www.taylorwessing.com/en/insights-and-events/insights/2022/05/new-polish-act-on-medical-devices-part-3

The Act also regulates inspection of business entities dealing with medical devices. The new regulations include, among others, powers to take samples of products …