About Regulatory Academy
The school this profession never had.
An independent online school for the people who bring drugs, biologics, and medical devices to the world. Structured mini-courses. Plain language. Every claim sourced to the primary record. All of it free.
Chapter 01 — The Problem
Nobody is taught regulatory affairs.
There is no degree that makes you ready, no residency, no bar exam. The people responsible for the most consequential decisions in life science are expected to assemble their own education — after hours, alone, from whatever they can find.
What they find is scattered. It works, eventually, for some people. It is nobody’s idea of a school.
Chapter 02 — The Method
Courses. Only courses.
We publish nothing loose — no article graveyard, no content mill. Every subject becomes a mini-course: five focused lessons in a deliberate order, closed by a quiz. Sequence is what turns information into competence. Here is a real one:
Chapter 03 — The Standard
Four rules govern everything we publish.
A beginning, an order, an end. Nothing is ever published loose.
The regulation, the statute, the guidance — linked, not paraphrased.
Written like a good mentor explains. No jargon walls, no dumbing down.
No paywall, no lead-gate, no trial clock. Open to anyone, always.
A 510(k) does not ask whether your device is safe in the abstract. It asks whether the device is substantially equivalent to a legally marketed predicate — same intended use, and either the same technological characteristics or differences that raise no new questions of safety and effectiveness.[1]
See the primary sources behind that sentence
Chapter 04 — The Promise
The seats are free. All of them.
The fundamentals of this profession should not sit behind a paywall — the world is safer when the people doing this work are well taught. So the Academy’s door stays open, and a new course drops every month, announced first in the Academy Briefing.
Every lesson of every course, readable by anyone, start to finish.
No account, no gated PDF, no “enter your work email to continue.”
The course is the product. There is no “full version” waiting behind it.
How we build courses
How this material is made.
Every course and guide is built from the instrument it teaches — the CFR section, the FDA guidance, the ISO standard — and cites it, so you can go and read the thing itself once you understand the shape of it.
Drafting is AI-assisted. An internal pipeline reads those primary documents and produces a structured first draft against a fixed lesson template. Every lesson is then reviewed against its sources, edited and published by Connor Griggs, a regulatory affairs professional who began his career at the FDA. Nothing publishes itself.
One caveat worth stating plainly: course material explains regulation, it is not regulation. When a requirement matters to your submission, read the instrument — we link it every time for exactly that reason.
From the newsroom
Learn it here. Watch it move there.
Regulatory News is our independent newsroom — every story sourced to the primary record, published the day it lands. These are the beats behind this lesson. RegulatoryNews.com →
- GuidanceDraft and final guidance, as it lands.
- ClinicalTrials, INDs, holds and study design.
- ManufacturingCMC, GMP inspections and supply.
- Key datesDeadlines and comment periods, in one calendar.
- Industry SpotlightCompany milestones, reported in depth.
- Full archiveEvery story we have published, searchable.
Class is in session.
Five lessons on how medical devices actually reach the U.S. market, from choosing a predicate to clearance day. Your seat is already paid for.
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