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: Medical Devices
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
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
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
November 4, 2023
FDA Warning Letter Issued for Non-Validated AI Code Claimed “For Research Use Only”
FDA recently issued a warning letter to Wavi that claimed its AI code used for its Wavi Desktop product was “for research use only” and not subject to FDA regulation. This is not a judgement on Wavi as…Read More
October 19, 2023
CDRH Proposed Guidances for Fiscal Year 2024 Related to Artificial Intelligence/Machine Learning (AI/ML) Enabled Device Software Functions
It is encouraging to see the FDA’s Center for Devices and Radiological Health (CDRH) has signaled in their proposed guidances for fiscal year 2024 (FY2024) that guidances related to Artificial Intelligence/Machine Learning (AI/ML) are getting a high priority…Read More
September 28, 2023
FDA Transition Plan in Action as Demonstrated by Akili EndeavorOTC Product
In March 2023, the FDA released a final guidance titled “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency“, which at high level set out a timeline…Read More
August 24, 2023
Follow-up On AI Enabled Medical Devices with Recent De Novo Classifications
Two devices with recent De Novo Classifications were reported on recently in the Viz.ai HCM and Better Therapeutics devices that employ Artificial Intelligence (AI) and/or Machine Learning (ML). The Classification Order for both were recently published and present…Read More
