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.
After months of delay, the FDA and the device industry have reached an agreement in principle on the agency’s commitments for the fifth iteration of the Medical Device User Fee Act (MDUFA) – for fiscal years 2023 to 2027 — but the two sides are still working out details of a commitment letter that was due to Congress by Jan. 15. Read More
In a rare move by the FDA, the agency ordered Philips Respironics to notify patients and other customers of the company’s June 14, 2021, recall of certain models of its ventilators, continuous positive airway pressure (CPAP) and bilevel positive-airway pressure (BiPAP) machines. Read More
Whether a company is primarily a drug manufacturer or a device manufacturer, if it starts making combination products, it will have new additions to its quality management system (QMS) and will “need to learn to speak the language for both sides of the combination product,” according to a former FDA official. Read More
Israel-based Ibex Medical Analytics has partnered with Milan, Italy-based Dedalus to supply software products to help pathology labs “maintain high accuracy diagnosis levels and reduce diagnosis times.” Read More
A majority of “smart” infusion pumps are vulnerable to hacking, in many cases because of software flaws that have long been known, according to a report by Palo Alto Networks, a Santa Clara, Calif.-based cybersecurity company. Read More
Integra LifeScience’s TEI Biosciences drew a six-observation Form 483 from the FDA based on an inspection last October and November of the company’s facility in Boston, Mass. Read More
The FDA has issued a warning letter to Wickimed Medical Equipment Manufacturing for violations of good manufacturing practices (GMP) in making its sterile single-use disposable electrodes. Read More