Walk the Pathway Choice
Choose the next regulatory pathway question based on class, exemption, predicate, and risk.
The shortcut A team assumes 510(k) because most devices they have heard about use that route. A wrong pathway assumption can waste months before the real evidence question is visible. Pathway logic Class, exemption, predicate, risk Start with classification, then ask whether premarket review is exempt, whether a predicate supports substantial equivalence, or whether novel risk points toward De Novo or PMA. Shortcut Call it a 510(k) because it sounds familiar A defensible next regulatory question The pathway follows the device type and risk controls. Classification first Step 1 The product team says the wearable is a low-risk device. What…
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