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An upstream occlusion alarm in certain of B. Braun’s infusion pumps that may sound when no occlusion exists and cause the pump to stop pumping caused the company to issue a recall on Sept. 23, which the FDA has now deemed as class I, the most serious type of recall. Read More
In a win for Masimo, the U.S. International Trade Commission (ITC) banned the importation of Apple watches with light-based oximetry technology that monitors heart rate and blood oxygen because the watches violate two patents held by Masimo. Read More
Over the past week, the FDA issued draft guidance on communications of off label uses of approved/cleared medical products and remote inspections of drug manufacturing and BIMO facilities. Read More
In this edition of Quick Notes, we cover a Philips study confirming the safety of its cardiac diagnostic device, FTC action against deceptive marketing of a COVID-19 protection device, and updates to two FDA medical device event reporting databases. Read More
Fresenius Medical Care has recalled some of its hemodialysis machines for the potential of exposing patients to a harmful chemical, and Olympus has recalled an insufflation unit — and the FDA has deemed both these recalls as class I, the most serious type of recall because of the potential for serious side effects including death. Read More
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on what to expect from the FDA in 2024, quality culture and how to use UDI and UDI Data. Read More
The FDA, Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly published guiding principles that lay the foundation for predetermined change control plans (PCCP) for machine learning enabled medical devices. Read More
While it might seem obvious, achieving effective corrective and preventive action (CAPA) plans requires diligence and consistent application of three core elements. Read More
With one in four medical devices incorporating some form of medical device software (MDSW), the European Council’s Medical Device Coordination Group (MDCG) has issued a guidance on the regulatory pathway or conformity assessment for the hardware or hardware components that comprise these devices. Read More