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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
A new final guidance advises devicemakers to include 11 categories of information in 510(k) submissions for catheter-based devices to treat peripheral vasculature lesions, including detailed device description, components and mode of operation, comparison with the predicate devices and other details. Read More
The FDA has laid out its current thinking on the adhesive performance and irritation potential of generic transdermal and topical drug delivery systems and clarified recommendations for designing safety and efficacy studies for these products, in a pair of revised draft guidances. Read More
Multiple devices and digital behavioral interventions have been approved or are in the works to help patients suffering from opioid use disorder (OUD), says FDA Commissioner Robert Califf, but obstacles such as a high failure rate and proof of efficacy stand in the way of wider adoption. Read More
Upcoming events in the coming weeks include nine 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
New FDA drug approvals in the past month include treatments for rare diseases and an aggressive form of skin cancer, as well as the first new treatment for invasive fungal infections in over a decade. Additionally, the FDA approved a new device for use in patients with arterial occlusive disease. Read More