Devices · Pre-marketing
Learn the work.
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The free explanations of this profession are mostly written by tool vendors. These are written by people who do the work, sourced to the regulation, and pitched at someone who already knows what the FDA is.
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Every lesson answers one question properly, cites the regulation it rests on, and assumes you are here to do the job rather than to skim.
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Drugs
INDs, NDAs & the CDER lifecycle
From first-in-human to approval — the submissions, the clocks, and the data behind them.
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Devices
510(k), PMA & the CDRH pathways
Predicates, substantial equivalence, and what clearance actually permits.
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Foundations
The concepts everything rests on
The framing, vocabulary and mechanics that make the rest of the library make sense.
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