What the FDA?
Steve SilvermanInsights on FDA device regulation and the effect on the MedTech community
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
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| Issues | 56 | Founded | a year ago | Last Issue | 11 days ago |
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steveilverman.substack.comLatest Issues
Device Firms May Want FDA Review (Even If They Don’t Need It)
In January, FDA published its revised General Wellness guidance, granting enforcement discretion to digital products that measure physiologic parameters (like heart rate variability and blood oxygen saturation). For many firms, that means n...
Credit Where It’s Due: The RAPID Coverage Pathway
Note to readers: when I saw the RAPID announcement last week, I thought, “that’s a good subject for my column. Readers will be interested and the topic won’t get too much coverage.” A week later, everybody’s written about RAPID (this mornin...
CDRH Hiring Needs Are Bigger Than the Numbers
What happened?[1]
Trump administration workforce reductions hit CDRH hard. In February 2025, DOGE-directed firings targeted probationary employees, including experts needed to oversee new technologies. More firings followed last April, rem...
Home Sweet Hub
CDRH recently launched the Home Innovation Challenge, which invites proposals for device technologies that support patients and caregivers after acute hospital stays. The challenge, part of CDRH’s Home as a Healthcare Hub program, is innocu...
FDA’s AI Device Guidance Is Stuck in Draft. That’s a problem.
FDA published draft guidance on AI-enabled device software functions in January 2025 and comments closed last April. Meanwhile, FDA cleared almost 300 AI/ML devices last year (a record), but the AI guidance remains unfinished. Worse, CDRH’s...
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Authors
The writers behind this newsletter.
Steve Silverman is the President of The Silverman Group, a consultancy that serves medical product companies on regulatory, strategy, and policy issues. Steve’s experience includes extensive time in senior FDA roles.
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