The Regulatory Academy Briefing
Learn the work
The free explanations of this profession are mostly written by people who have never done it. These are written by someone who has.
Connor Griggs · 8 min read
The Ledger
Regulations Change.
Learn to Change With Them.
Practical guidance on the regulations reshaping your work — written to be applied, not just read.
5 articles
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Jul 182026
How to choose a 510(k) predicate — and defend it
The predicate is not a formality. It is the question your entire file answers — so choose it the way the reviewer will read it, record by record.
Connor Griggs · 8 min read
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Jul 182026
Traditional, Special, or Abbreviated — choosing your 510(k)
Three doors into the same finding of substantial equivalence. The right one depends on what changed — and who holds the device it changed from.
Connor Griggs · 7 min read
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Jul 182026
Building the 510(k) — eSTAR, screening, and the testing burden
The file is a testing programme wrapped in a template. The template is mandatory now — and it will not let you leave the hard parts blank.
Connor Griggs · 8 min read
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Jul 182026
The 510(k) review — from submission to the SE letter
Ninety FDA days is not ninety calendar days. Here is the review as the tracker actually shows it — and the obligations that begin when the letter lands.
Connor Griggs · 7 min read
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Jul 162026
What a 510(k) actually is — and what clearance means
Everyone calls it “FDA approval for devices.” It is neither an approval nor about your device alone — and that difference decides the whole file.
Connor Griggs · 7 min read
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