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The FDA posted a series of frequently asked questions (FAQ) Thursday about the use “legacy” identification numbers for medical devices as the agency shifts to the Unique Device Identification (UDI) system. Read More
Cybersecurity doesn’t just apply to the products you are building today, it applies to legacy products still in use many years after installation — and devicemakers need to install post marketing updates that either bring these older devices up to today’s standards, or make them obsolete, advised one device security expert at the WCG-FDAnews Annual Inspections Summit in Washington, D.C., on Thursday. Read More
Johnson & Johnson (J&J) and its subsidiary Ethicon are seeking a review by the U.S. Supreme Court (SCOTUS) of the $302 million in imposed on them for misrepresenting the risk of their pelvic mesh products in marketing materials, arguing their due process rights were violated. Read More
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