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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
While Congress may have ended the “national emergency related to the COVID-19 pandemic” with a joint resolution President Biden signed into law on Monday, the public health emergency (PHE) declared by HHS Secretary Xavier Becerra will remain in effect another month. Read More
Bookshelves in Washington are filled with expert reports that have never been read and with recommendations that have never been implemented. Read More