The Regulatory Academy Briefing
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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 Regulatory Academy Briefing
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
Practical guidance on the regulations reshaping your work — written to be applied, not just read.
9 articles
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
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
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
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
Most of what FDA publishes is not law, and says so on the first page. Knowing what binds you — and what is the reviewer's yardstick — changes how you argue.
Connor Griggs · 7 min read
The one device pathway where “FDA-approved” is the right phrase — because for a Class III device there is no predicate to stand behind. Your evidence carries the whole file.
Connor Griggs · 7 min read
Teams plan launches around “the PDUFA date” as if the statute enforces it. It is a performance goal — and the letter that lands on it can be a Complete Response.
Connor Griggs · 7 min read
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
Most explanations call it “an application to the FDA.” That framing is why people wait for a letter that never comes.
Connor Griggs · 7 min read
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