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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Month: June 2026
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
