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’s budget would be set at $4.35 billion, an increase of $91 million from 2013, under an omnibus spending bill passed by Congress last week. Read More
While all FDA device investigators go through specialized training, combination products and foreign inspections can still pose challenges during the inspection process. Read More
Members of the Council of Europe are at odds over whether to allow reprocessing of single-use devices, and the disagreement could upend efforts to pass device reform legislation before EU elections in May. Read More
A recent appeals court hearing on the Securities and Exchange Commission’s conflict minerals disclosure rule provided no immediate relief for manufacturers — though the line of questioning suggested some judges were sympathetic to industry’s free speech argument against the rule. Read More
China’s National Health and Family Planning Commission plans to “blacklist” devicemakers convicted of bribing government officials and ban sales of their products for two years — four for repeat offenses. Read More
The Central Drugs Standard Control Organization has issued detailed guidance on the registration, reregistration and import of notified in vitro diagnostic kits and on the import of non-notified kits, with the aim of speeding submission reviews and easing the move to electronic submissions. Read More
AdvaMed and Taiwan’s medical device association have signed a memorandum of understanding aimed at supporting medtech innovation and advancing patient care. Read More