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.
SonarMed Airway monitors and sensors saw two separate Class I recalls for a restricted inner diameter in the airway and software that failed to detect the partial obstruction, while BioMérieux saw a Class I recall for an antibiotic sensitivity test kit that could produce inaccurate results. Read More
This edition of Quick Notes provides an overview of four recently released draft guidances on the manufacture of cell-based products and on the FDA’s enforcement policy regarding test manufacturers’ offering of certain unapproved tests during a future declared emergency or in the absence of such a declaration. Read More
The FDA is soliciting written feedback as well as presenters to speak on its use of and processes for its advisory committee during a virtual listening session scheduled for June 13. Read More
In the wake of Congress repeatedly trying and failing to pass the bipartisan Verifying Accurate, Leading-edge IVCT (In-Vitro Clinical Test) Development (VALID) Act, the FDA today announced its final rule declaring that in vitro diagnostic products (IVD) manufactured in a laboratory are now considered medical devices, and thus under the regulation of the FDA. Read More
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
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
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