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.
HHS’s fall unified agenda of proposed rules for the FDA includes a new rule that revokes two old rules that have either been superseded or do not reflect current agency practice, the agenda says. Read More
A survey conducted among attendees of Team NB’s second in vitro device regulation (IVDR) training seminar reflected the worrisome trend of foot-dragging among manufacturers in making an application to a Notified Body for approval of devices under the new EU medical device regulations. Read More
As the comment period closed Wednesday on a trio of FDA draft guidances covering data requirements for 510(k) device submissions, industry trade group AdvaMed expressed its clear concerns that the guidances exceeded the agency’s regulatory scope. Read More
The FDA has updated its eSTAR online medical device 510(k) application submission process — which became mandatory as of Oct. 1 — to include additional submission types. Read More
Cordis’s recall of Infiniti angiographic catheters for lack of sterilization has been identified by the FDA as a Class I recall, the most serious type of recall as use of these devices may cause serious injuries or death. Read More
AdvaMed, a trade group for medical devicemakers, did not submit a public comment but instead issued a statement on the subject in late September. Read More
Recalled glucose capsules marketed as a health supplement for blood glucose control were found to contain glyburide and metformin — drugs that treat type 2 diabetes by lowering blood sugar — were deemed a Class I recall by the FDA, the most serious type of recall as use may cause serious injuries or death. Read More
In a strongly worded position paper, the European Commission’s Medical Device Coordination Group (MDCG) has directed device manufacturers to get certified ASAP under the new device and diagnostics regulations. Read More