On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System ...

On April 11, AEI’s Brian J. Miller hosted Jesse Ehrenfeld of the American Medical Association and Jeff Shuren of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health to ...

Whether you manufacture a Class I elastic bandage or a Class III deep-brain stimulation device, understanding when to report a medical device complaint is critical and is also required for all FDA ...

Regulatory Outlook Medical Device Clinical Trials in Japan In an effort to globally harmonize medical device clinical trials, Japan has implemented new regulations on how to develop and conduct them.

The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.

The Medical Device Amendments of 1976 were supposed to be written up and put into law in the early 1960s. But, as Peter Barton Hutt told MD+DI in a 1996 interview about the development of the Medical ...

A new white paper aiming to help companies safely design, launch and maintain AI‑enabled medical devices across major global markets has been published by regulatory consultancy IMed Group and ...

"A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the ...

A medical device is an umbrella term for any instrument, software, or other article used alone or in combination for a medical purpose in humans. An estimated 2 million different kinds of medical ...

The European Union has released two significant guideline changes to expand its medical device framework, updating the classification rules for medical device software to include app platform ...