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.
Get a second opinion on your FDA strategy before you commit to testing or submission work.
Falcr’s fixed-fee Regulatory Pathway Brief covers one device, one proposed intended use and one agreed US FDA question. Tell us the decision you are approaching and we’ll reply about fit.
These guides are plain-language orientation from public sources. They are not a classification, pathway or conformity assessment determination for a specific device.