GUIDES
Regulatory pathway guides
Short, source-linked orientation pages on the decisions that shape a medical device regulatory pathway. Each page explains how a framework works in public terms. None of them is a classification, pathway or conformity assessment determination for a specific device.
PUBLIC SOURCES · PLAIN-LANGUAGE ORIENTATION · NOT REGULATORY ADVICE
CLASSIFICATION
Medical device classification: FDA, TGA and EU MDR compared
How each framework sets class, and what that implies for the route to market.
FDA PREMARKET ROUTES
FDA 510(k), De Novo and PMA: how the three routes differ
510(k), De Novo and PMA compared, and what usually decides between them.
PREDICATE DEVICES
Choosing a predicate device: what the comparison has to survive
What a predicate is, how candidates are found, and why comparisons fail.
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These guides are plain-language orientation from public sources. They are not a classification, pathway or conformity assessment determination for a specific device.