I see a lot of 510(k)s and de novos in the course of my work, so it is always inspiring to see something truly groundbreaking make it through the FDA. The recent de novo from Cardiosense announced last week…Read More
June 5, 2026
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Category: Commentary
May 22, 2026
The Hunt for the Next FDA Commissioner
It is last weeks news that FDA’s leadership turnover has been the highest in memory, possibly ever. What should concern everyone is the response of industry to this degree of uncertainty at FDA. Drug company Regenxbio last week…Read More
March 12, 2026
FDA holds virtual Town Hall meeting on Clinical Decision Support guidance update
The FDA held a virtual town hall on March 11th, 2026 on the Clinical Decision Support (CDS) Software guidance update, which published on January 6th, 2026 and republished on January 29, 2026. This was an eagerly awaited event to…Read More
February 12, 2026
FDA holds virtual Town Hall meeting on recent General Wellness guidance update
The FDA held a virtual town hall today (February 11th, 2026) on the General Wellness guidance update which published on January 6th, 2026. This was a highly anticipated event to address questions on the guidance, which was reported…Read More
January 7, 2026
FDA releases update to Clinical Decision Support Software guidance that expands non–regulated opportunities for AI industry
The FDA released an update to the Clinical Decision Support Software (CDS software) guidance yesterday (January 6, 2026) in what was a surprise move to virtually all in the FDA regulatory space. To put some historical context on…Read More
January 6, 2026
FDA releases update to General Wellness guidance that creates new opportunities for industry to operate without FDA regulation
The FDA released a final guidance update to the General Wellness: Policy for Low Risk Devices today (January 6, 2026) in what could only be characterized as a sudden and momentous event. It is worth noting that this…Read More
December 18, 2025
Proposed amendment to EU MDR could relax rules on AI medical device software
There was recent news for the possible relaxation of rules for MDR with respect to medical device software (MDSW), including for MDSW utilizing artificial intelligence (AI). The December 16, 2025 proposed amendment to classification rules for MDSW for…Read More
December 9, 2025
Industry players request that FDA Center for Devices and Radiological Health (CDRH) withdraw certain guidances and prioritize other guidances in fiscal year 2026
The comment period for the CDRH fiscal year 2026 (FY 2026) proposed guidance development closed on December 1, 2026 and it was reported recently in RAPS that certain industry participants officially asked both for withdrawal of certain guidances…Read More
August 12, 2025
A False Claims Act (FCA) suit due to not meeting FDA cybersecurity requirements and the implications on other possible FCA actions
Illumina is paying about $10 million because they sold FDA regulated products to the US Government that weren’t meeting FDA cybersecurity requirements for a regulated device, not for an actual cybersecurity breach. One has to wonder what other…Read More
August 11, 2025
Illinois prohibits the use of AI to provide mental health and therapeutic decision-making
The Illinois Governor signed into law last week The Wellness and Oversight for Psychological Resources Act which prohibits the use of AI to provide mental health and therapeutic decision-making, but allows the use of AI for administrative and…Read More
