IDE, IRB, ClinicalTrials.gov - generate the data FDA and CMS both want
Most 510(k)s do not require a clinical study; most De Novos and all PMAs do. Even if FDA doesn't require evidence, CMS will - design the trial endpoints to satisfy both regulators and payers in a single study. Foreign data can support a 510(k) but rarely a PMA without US enrollment.
If the study presents serious risk to subjects, you need an FDA IDE before enrolling. Non-significant-risk studies follow abbreviated IDE requirements with IRB approval only. Get the SR/NSR determination wrong and you've conducted an unauthorized clinical investigation.
FDA cares about safety and effectiveness vs the predicate. CMS cares about clinically meaningful outcomes vs current standard of care. A trial designed only for FDA often fails to support a coverage decision later - costing 2–4 years and another trial.
Commercial IRBs (WCG, Advarra) approve in weeks; academic IRBs can take months. Pick sites with prior IDE experience for your indication - they have established workflows for FDA reporting requirements.