HeyJaredMedical Device Regulatory Briefing
Deep-dive insights on FDA regulation, claims, and commercialization strategy in medtech.
- Indexed issues, last 90 days
- 12
- Latest publication
- Sep 29, 2026
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- Aug 11, 2026
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“FDA Cleared” Means the Regulatory Work Is Mostly Done (opens the original)
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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 with the regulatory work being mostly over.That’s the myth.Once the device leaves the controlled world of the submission and enters the much messier world of manufacturing, distribution, sales, customers, complaints, and actual use, the risk does not disappear. It ch
Structured Submissions Leave Less Room for a Messy Regulatory Story (opens the original)
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FDA keeps making medical device submissions more structured.Now PMAs are moving further into eSTAR.FDA’s Sept. 18 draft guidance lays out the electronic submission format for original PMAs and certain supplements.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 available voluntarily, and FDA is proposing at least a one-year transition after the guidance is finalized before required use begins.Fine.But the part I find more interesting is what happens when you force a very large submission into a more structured format.The
A Faster FDA Pathway Is Not a Shortcut Around Regulatory Strategy (opens the original)
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“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 product, it can absolutely create efficiency.But let’s kill the myth now:A faster pathway does not fix a weak regulatory strategy.If the predicate choice is shaky, the testing plan is thin, or the claims don’t line up cleanly with t
Your Supplier’s Quality Problem Can Become Your Remediation Problem (opens the original)
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FDA’s recall pages have been looking a little repetitive lately.Different products. Different companies. Same uncomfortable pattern.A component has a problem, and the consequences start moving downstream.We’ve been watching this in recent FDA Early Alerts involving convenience kits. In several cases, the issue started with a component inside the kit rather than with the finished kit itself.That doesn’t make the downstream problem disappear.Once that component is part of your product, you may be
Your Biocompatibility Strategy Should Start Before the Lab (opens the original)
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Biocompatibility conversations have a funny way of starting with the lab.What tests do we need?Fair question.I just wouldn’t make it the first one.FDA is holding a Biocompatibility Risk Assessment Town Hall on September 9 to discuss recent updates to ISO 10993-1:2025 and approaches to evaluating biocompatibility risk.And the emphasis is clear: risk assessment.Before a test strategy makes sense, the team should understand what it is trying to lear
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