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.
Philips Respironics has informed the FDA of two new potential issues with its reworked Trilogy ventilators that were part of a June 2021 recall. Read More
Devicemakers need to be prepared to comment as the FDA rolls out guidance related to the incorporation of ISO 13485:2016 into the FDA’s proposed Quality Management System Regulation (QMSR), said a former senior agency official at the WCG FDAnews 17th Annual FDA Inspections Summit in Washington, D.C. Read More
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