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The FDA wants its Radiological Devices Advisory Panel to weigh in on whether irradiators used to prevent metastasis in salvaged blood during cancer surgeries are safe enough to be classified as Class II devices or whether, as the FDA proposes, they should be designated as high-risk Class III devices requiring premarket approval. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
The FDA is also proposing to exempt certain clinical electronic thermometers without telethermography from premarket notification requirements. Read More
With the looming expiration of temporary government funding on Nov. 17, lawmakers face significant challenges to reconciling the House and Senate versions of fiscal 2024 appropriations bills — including one to fund the FDA. Read More
Many pre-approval inspections that were in limbo because of the backlog during the pandemic are now going ahead and the uptick could result in more product approvals, according to regulatory attorney Cathy Burgess, a partner in the law firm Alston & Bird. Read More
Over the past week, the FDA issued final guidances on enforcement for certain supplements for PMA or HDE submissions and clinical electronic thermometers enforcement policy. The agency is also proposing to exempt certain clinical electronic thermometers without telethermography from premarket notification requirements. Read More
In a guidance set to go into effect immediately, the FDA has made permanent the enforcement policy for use of clinical electronic thermometers it set during the COVID-19 public health emergency. Read More
Upcoming events in the coming weeks include three FDA advisory committee meetings as well as the 18th Annual Inspections vSummit from FDAnews, a WCG company, and webinars on how to use UDI and UDI Data, the importance of selecting the right partner for independent expert committees, choosing the right IRB review partner and medical device cybersecurity. Read More
A new FDA guidance set to take effect immediately extends the agency’s COVID-era policies requiring supplementary submissions for certain modifications to a device approved under the premarket approval (PMA) or humanitarian device exemption (HDE) pathways. Read More