A recent study led by researchers at the Yale School of Medicine and Harvard Medical School found that a loophole in existing regulation has allowed manufacturers to acquire U.S. Food and Drug ...
The European Commission adopted Implementing Regulation (EU) 2021/2226 which establishes the conditions under which instructions for use of certain medical devices subject to the Medical Devices ...
On 23 March 2023 the new Spanish Medical Devices Regulation (Spanish MDR) came into force. After a lengthy wait, the medical devices industry (and any other interested sector) finally has access to ...
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 ...
Due to the increasing concerns about medical devices' cybersecurity risks, European Union regulators put forward a new set of market entry requirements for medical devices and in vitro diagnostic ...
DUBLIN--(BUSINESS WIRE)--The "An Introduction to the Medical Device Regulation" conference has been added to Research and Markets' offering. Gain a comprehensive understanding of the regulatory ...
An FDA proposal to require device manufacturers and hospitals to adopt a universal bar code system or other technology to identify individual devices is expected to be published in Wednesday's Federal ...
Recently, there has been a robust discussion of an October Trump administration proposal that Medicare pay for certain prescription drugs based on an “international pricing index” determined by prices ...
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