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.
A newly updated “playbook” issued by MITRE under contract with the FDA aims to help hospitals integrate medical device cybersecurity into their emergency plans. Read More
Sponsors of medical devices will see increased user fees under the recently reauthorized Medical Device User Fee Amendments (MDUFA) V, but they can also look forward to more rapid submissions and approvals under a new user fee funded pilot program, according to one Washington D.C.-based regulatory attorney. Read More
In response to requests for a later deadline, the FDA has granted more time to comment on a pair of long-awaited proposed rules on institutional review board (IRB) reviews and informed consent requirements for clinical trials, pushing back the deadline until Dec. 28. Read More
Although counterfeit devices may meet the definition of a “device,” the FDA will not be treating them as such, the agency says in a final guidance released yesterday. Read More
The FDA’s Ophthalmic Devices Panel met Thursday and reached consensus that unfilled/empty eye cup and “droptainer” ophthalmic devices — currently unclassified — should be considered Class I with general controls, as recommended by the FDA. Read More
The FDA has granted Breakthrough Device designations for Avita Medical’s Recell System for soft tissue repair and vitiligo – a condition in which the skin loses its pigment. Read More
Allotrope Medical has received the FDA’s Safer Technologies Program (STeP) designation for its StimSite surgical device, which helps surgeons locate and identify the ureter during abdominal surgery, reducing post-surgery cystoscopy time. Read More
The EU’s Medical Device Coordination Group (MDCG) has released new guidance on requirements created by the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) for devicemakers’ “authorized representatives,” including who, when and how to register. Read More
The average total review time declined from 170 calendar days in 2018 to 126 in 2022, but there was a pandemic-related spike to 190 days in 2020. Read More