Which pathway should you file?
Side-by-side breakdowns of the regulatory decisions regulated-hardware teams face — structured, sourced, and built to settle the choice.
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510(k) vs De Novo
File a 510(k) when your device is substantially equivalent to a legally marketed predicate. Use the De Novo route when your device is novel and low-to-moderate risk but has no predicate — it would otherwise default to Class III. De Novo creates a new classification and is slower and more expensive, but it makes your device a future predicate.
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MDD (93/42/EEC) vs MDR (2017/745)
The EU Medical Device Regulation (2017/745) replaced the Medical Device Directive (93/42/EEC). It widens scope, up-classifies most software, demands far more clinical evidence and post-market surveillance, mandates UDI and EUDAMED, and requires re-certification by a notified body. Legacy MDD devices must transition by 31 December 2027 or 2028 depending on class.
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PMTA (section 910) vs Substantial Equivalence (section 905(j))
A PMTA (section 910) proves a new tobacco product is appropriate for the protection of public health from its own evidence — the default route for novel products like most ENDS. A Substantial Equivalence report (section 905(j)) instead shows the product is equivalent to a predicate marketed as of 15 February 2007. SE is lighter but needs a valid predicate; without one, PMTA is the only route.