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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The arena of digital health and FDA regulations that apply to apps, wearables and software, including artificial intelligence (AI) and machine learning (ML) continue to evolve in the United States. See select articles and tweets for latest news one these topics here.
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FDA Releases New Final Guidance Exempting Some Products from Premarket Notification Requirements
The FDA released a new final guidance yesterday titled “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.” A total of 13 product codes across 8 FDA review divisions were listed in the guidance that will…Read More
June 1, 2026
Positive FDA development with recent release of final guidance for Content of Human Factors Information in Medical Device Marketing Submissions
The FDA released last week the final guidance titled Content of Human Factors Information in Medical Device Marketing Submissions. This shows the commitment of the FDA to pursue a rational risk-based framework to guide manufacturers and FDA staff…Read More
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
