regulatory-affairs-head

FDA 510(k) submissions require predicate device comparison, performance testing documentation, software documentation if applicable, and labeling with indications for use. The FDA review typically takes 90 days after a 15-day administrative completeness check.

510(k) clears Class II devices through substantial equivalence to a predicate. PMA is a full safety and effectiveness review for Class III devices, usually requiring clinical data. De Novo classifies novel low-to-moderate risk devices that have no predicate.

EU MDR requires technical documentation per Annex II, an ISO 13485 quality management system, clinical evidence per Annex XIV, a post-market surveillance plan, and UDI registration. Higher classes require Notified Body assessment.

The regulatory_tracker.py script stores submissions in a JSON file with status, dates, and authority fields. It generates status reports, lists submissions by state, and flags items past their target approval date.

Engage a Notified Body early, during the pre-submission phase 6-12 months before filing. Late engagement is a common pitfall that delays certification, especially for Class IIa, IIb, and III devices requiring conformity assessment.