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FDA splits devices into Class I, II, or III based on how risky they are.
- Class II (510(k)): Most drug delivery gadgets—like infusion pumps, autoinjectors, and inhalers—are Class II, so they usually need a 510(k).
- Class III (PMA): Higher-risk stuff (like implantable drug pumps) is Class III, which calls for a Premarket Approval (PMA) instead.
- When You Need a 510(k): If your device is “substantially equivalent” to something already out there or making a new tweak to an existing device that impacts safety or effectiveness or you’ve got a standalone device that doesn’t include a drug component.
- When You Don’t Need a 510(k): If it’s part of a drug-device combo (like a prefilled syringe) that’s regulated under the drug pathway or a Class I device that the FDA specifically exempts (like a basic syringe) or covered by a PMA.