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The FDA has slapped Abbott Point of Care Canada with a warning letter for marketing a product with design and component changes without applying to the agency for clearance or approval. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More
The top citations in FDA warning letters tend not to change radically from one year to the next, but the agency’s warning letters for fiscal 2022 hint at an increased focus on component testing and contractor oversight. Read More
Wirelessly connected infusion pumps, nurse call systems and medication dispensing systems are highly vulnerable to malicious activity, according to new research by security company Armis.
There are several “green” pathways to help expedite overseas medical device and in vitro diagnostics (IVD) approval in China — including the innovation, priority and emergency use pathways, as well as special zone policies. Read More
The replacements come from the June 2021 recall of certain ventilators, bilevel positive airway pressure machines, and continuous positive airway pressure machines. Read More
The FDA’s Office of Regulatory Affairs (ORA) needs technological advances to create “one source of truth” rather than the siloed data systems that currently hamper its efforts to modernize inspectional work, according to its chief. Read More
New final guidances from the International Medical Device Regulators Forum (IMDRF) explain how to identify and address cybersecurity risks in older devices containing software and offer advice on large-scale manufacturing and validation of personalized devices. Read More
Over the past week, the FDA issued two final and three draft guidances, as well as requests for comments on several advisory committee meetings, user fees, IND applications and the agency’s data and technology strategic plan. In addition, CDRH released details of the center’s Radiation Sterilization Master File Pilot Program. Read More