We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA and the Department of Homeland Security have flagged cybersecurity weaknesses in some St. Jude Medical implantable cardiac devices used with the company’s Merlin@home transmitters. Read More
The FDA finalized guidance on GMP requirements for combination product manufacturers, adding scenarios to clarify how to comply with certain device requirements. Read More
The China Food and Drug Administration (CFDA) has issued new guidance on quality control, finished product inspection, and other procedures for medical devices. Read More
Most of the provisions in the 21st Century Cures Act clarifying medical software regulation are straightforward and welcomed by industry, but it is unclear how the FDA will apply a provision on clinical decision support software. Read More
Every medical device imported into Malaysia for sale must have a single authorized representative, according to a new circular from the country’s Medical Device Authority. Read More