Medical Device Regulatory Briefing
leanRAQADeep-dive insights on FDA regulation, claims, and commercialization strategy in medtech.
| Platform |  | Pricing | Only free issues | Publishes | Twice weekly |
|---|---|---|---|---|---|
| Issues | 66 | Founded | 9 months ago | Last Issue | 6 days ago |
| Active | |||||
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Stop Asking for the Minimum
When I advise the CEO of an early-stage medical device company, there is one question I absolutely challenge: “What is the minimum we need to do to get through FDA?”
I get why people ask it. Money is finite. Runway is real. Nobody gets a m...
QMSR Inspections: What Happens When FDA Starts Pulling Threads?
QMSR has been in effect since February, which means most companies have already updated procedures, retrained people, and checked the transition boxes.
Great.
Now I want to know whether the quality system actually holds together when some...
“FDA Cleared” Means the Regulatory Work Is Mostly Done
I love a clearance letter. Everybody does.
Months of work, reviewer questions, internal debates, probably at least one moment when somebody asked, “Do we really need that?” and then finally:
Cleared.
Celebrate it. Just don’t confuse it w...
Structured Submissions Leave Less Room for a Messy Regulatory Story
FDA keeps making medical device submissions more structured.
Now PMAs are moving further into eSTAR.
FDA’s Sept. 18 draft guidance lays out the electronic submission format for original PMAs and certain supplements. PMA eSTAR is already a...
A Faster FDA Pathway Is Not a Shortcut Around Regulatory Strategy
“Faster pathway” has a way of making people dangerously optimistic.
Great. So this should be easier.
Not quite.
FDA’s 510(k) Third Party Review Program gives certain low- to moderate-risk devices another review route. For the right produ...
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| Subscribers | Engagement | 65 | Monthly Web Visits | ||
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Authors
The writers behind this newsletter.
I help medical technology innovators bring safe, effective products to market—without losing their minds to regulatory chaos.
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