Decision tree
Three questions in order: Is there a legally marketed predicate device with the same intended use and technological characteristics? If yes → 510(k). If no, is the risk low-to-moderate? If yes → De Novo. If high-risk Class III → PMA.
Step 02 of 7 · Roadmap
Regulatory Pathway
510(k), De Novo, or PMA - and the Pre-Sub that de-risks each
When to start
After a working prototype + intended use statement; before any clinical study
Duration
510(k): 6–12 months FDA review · De Novo: 9–15 months · PMA: 18–36+ months
Indicative cost
USD 50K–200K (510(k)) · 200K–600K (De Novo) · 1M–10M+ (PMA)
Pathway selection determines your timeline, capital needs, and exit comparables. Search the FDA classification database for your three-letter product code first; if a predicate exists, you're likely 510(k). If none exists, you're De Novo. If your device is high-risk Class III, you're PMA - plan for clinical trials and a multi-year timeline.
Use the Pre-Sub program
The single highest-ROI step in your entire program. FDA returns written feedback in ~75 days on your proposed pathway, predicate, performance testing, and clinical strategy - for free. Founders who skip Pre-Sub typically pay 3–10× the cost in re-testing.
Pass the RTA gate
Refuse to Accept (RTA) is FDA's 15-day administrative completeness check. A submission that fails RTA is bounced before substantive review. Run your package against the RTA checklist line-by-line before you pay the user fee.