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AdvaMed announced the establishment of a new medical imaging technology division that will advocate on behalf of large and small devicemakers, and is establishing itself as the new home for advocacy, supplanting the Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association. Read More
Getinge’s recall of its Cardiohelp for problems with its emergency drive 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
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fall unified agenda of proposed rules for the FDA includes a new rule that revokes two old rules that have either been superseded or do not reflect current agency practice, the agenda says.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
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. 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
Over the past week, the FDA issued final guidance on verification systems for certain prescription drugs under the Drug Supply Chain Security Act and draft guidances on the interim policy on compounding using bulk drug substances under Section 503A and 503B of the FD&C Act. 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
Medtronic notified EOFlow on Dec. 6 that it exercised its right to terminate its agreement to acquire the company based on multiple breaches, according to a Securities Exchange Commission Form 8-K. Read More