Tag:
medical device regulations
Latest Headlines
Latest Headlines
FDA unveils streamlined de novo guidelines
The FDA has proposed new guidelines for the de novo clearance process that the agency says could shave 90 days off approval period of some devices. Currently, only devices that have already been
Report: EU device regulations as safe as those in U.S.
An industry-funded report argues medical device regulations in Europe are as safe as those in the U.S., even though the Continental system is thought to be much faster. The report, released Friday,
