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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
The proposed regulation to curb ethylene oxide (EtO) emissions would bring some surgeries and other medical procedures to a screeching halt, a medical device industry representative told a congressional subcommittee on Wednesday. Read More
The FDA has issued a draft guidance intended to strike a balance between health care providers’ interest in scientific information on unapproved uses of approved/cleared medical products and mitigating the FDA’s interest in prohibiting use of a product for an unapproved indication. Read More
In this edition of Quick Notes, we cover another Philips ventilator recall, GE HealthCare and Novo Nordisk collaborate to develop a diabetes and obesity ultrasound treatment and 510(k) clearance for Insulet’s Omnipod 5 App for iPhone. Read More
In this edition of Quick Notes, we cover a pharmaceutical ingredient cartel, fake Ozempic pens and new transparency rules for the European Medicines Agency clinical trial information system. Read More
Taking effect immediately is a guidance on non-invasive remote monitoring devices that gather patient physiological data from afar, reducing the need for in-office or in-hospital services. Read More