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Heightened regulation of mobile health apps and notification requirements for entities not covered under HIPAA are included in the final changes to the FTC’s Health Breach Notification Rule (HBNR) unveiled Friday. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
A biopsy needle designed for use with a system that helps locate and diagnose brain tumors has been recalled by the manufacturer, Elekta Instrument AB, and is now deemed a Class I recall by the FDA for its potential for leaving microscopic steel debris in the brain. Read More
The letter states that Philips failed to ensure its supplier’s validation of the injection molding process for its CT patient interface monitor. Read More
In this edition of Quick Notes, the FDA has elevated four device recalls to Class I, including an infusion pump that has caused six injuries and one death, two PCB-leaching brands of dialysis tubing, and an anesthesia machine that might simply shut off if used on battery power. Read More
This week, the European Parliament adopted the European Commission’s (EC) proposal to grant more time for companies to come into compliance with 2022’s In Vitro Diagnostic Medical Devices Regulation (IVDR). Read More
Cardinal Health received an FDA Warning Letter because the company is marketing Monoject convenience kits that include 3 mL, 10 mL, and 20 mL piston syringes and control syringes made by Chinese manufacturer Jiangsu Shenli Medical Production. Read More
This week, the FDA announced a Medical Devices Advisory Committee meeting, availability of a report on postmarketing performance of drug firms, revised draft guidance on biologic promotional labeling and advertising, three draft guidances on cancer clinical trial eligibility criteria, and a request for comments on promoting effective drug development. Read More
Inadequate responses to the findings of an October 2023 FDA inspection of Royal Philips’ Suzhou, China, facility has earned the company a Warning Letter citing the risks of malfunctioning of cable connection failure and software defects. Read More
With an aim of supporting patients, medical device developers and policymakers, the CDRH has launched a new initiative to deliver virtual reality-enabled models for use in the development of home-based care solutions. Read More