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1 day ago | 
bioworld.com | Mark McCarty
FDA rapidly lists raft of class I device recallsThe U.S. FDA posted notice of six class I device recalls between June 3 and June 5, 2025, four of which are for corrections. BioWorld MedTech Regulatory U.S. CDRH FDA
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2 days ago | 
bioworld.com | Mark McCarty
FDA’s device center playing guidance catch-upThe U.S. FDA’s Center for Devices and Radiological Health is recovering from a guidance drought that spanned several months in the first part of calendar year 2025, starting with a guidance on the Q-sub process. BioWorld MedTech Regulatory Gynecology/obstetrics U.S. FDA
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3 days ago | 
bioworld.com | Mark McCarty
Telemedicine at the root of false claims conviction for more than $1BU.S. Medicare coverage of telehealth and telemedicine sometimes seems to lag inappropriately, but fears of fraud were borne out in a conviction obtained recently by the Department of Justice. BioWorld MedTech Regulatory U.S.
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3 days ago | 
bioworld.com | Mark McCarty
FTC active again in enforcement of contact lens ruleThe U.S. Federal Trade Commission said it sent letters to 37 contact lens prescribers reminding them a failure to automatically provide patients with a prescription can result in fines of more than $53,000 per violation. BioWorld MedTech Regulatory U.S. FTC
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4 days ago | 
bioworld.com | Mark McCarty
NICE says new tech may no longer be required to save on costsThe U.K. National Institute for Health and Care Excellence reported it will streamline its health technology assessment, but the bigger news might be that the agency will no longer require new technologies prove to be cost saving to win an endorsement from the agency. BioWorld MedTech Regulatory Europe NICE
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4 days ago | 
bioworld.com | Mark McCarty
FDA’s Makary vows in-house AI algorithm won’t leak dataThe U.S. FDA reported the launch of its in-house generative AI (GenAI) tool, dubbed Elsa, for a variety of purposes. FDA commissioner Marty Makary assuaged industry’s privacy concerns by promising that the algorithm does not train on data submitted by makers of devices and pharmaceuticals. BioWorld MedTech Regulatory Artificial intelligence FDA
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5 days ago | 
bioworld.com | Mark McCarty
White House budget proposal would cut FDA, slash NIH budgetsThe Trump administration released its budget proposal for fiscal year 2026, which would chop roughly 40% from the NIH budget over the current fiscal year — a proposal that might not find much support on Capitol Hill. BioWorld MedTech U.S. FDA NIH Policy
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5 days ago | 
bioworld.com | Mark McCarty
Home » FDA declines to appeal court loss in LDT litigationFDA declines to appeal court loss in LDT litigationThe U.S. FDA declined to appeal the outcome of a lawsuit eviscerating the agency’s final rule for regulation of lab-developed tests despite a 60-day window to do so. BioWorld MedTech Regulatory Diagnostics U.S. FDA
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1 week ago | 
bioworld.com | Mark McCarty
Trump DOJ proposes less intrusive corporate prosecutionThe U.S. Department of Justice is reshuffling its enforcement focus for the coming three years per a May 12 memo attributed to Matthew Galeotti, director of the department’s criminal division. Galeotti said federal attorneys should avoid prosecutorial adventurism in an effort to strike what he described as “an appropriate balance” between enforcement and “unnecessary burdens on American enterprise.”BioWorld MedTech Regulatory U.S. FTC Policy
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1 week ago | 
bioworld.com | Mark McCarty
FDA agrees to addition of policy experts at Q-sub meetingsThe U.S. FDA’s device guidance drought ended with the issuance of one draft and one final guidance, the latter of which deals with the Q-sub program for early interaction with sponsors of device applications. Per a request by industry, the agency indicated it is amenable to including FDA policy staff during these meetings, which may help to avoid surprises in premarket applications. BioWorld BioWorld MedTech Regulatory U.S. FDA Policy
