US FDA Regulatory Strategy + Pathway

For this call I would brief you on:

1.Regulatory Strategy & Available Pathways and Cater feasible pathway for your medical device

2.Provide assistance on 510(k) Premarket Notification Preparation- Steps, explaining the workflow (Predicate device comparison, Substantial equivalence analysis, Performance testing gap analysis,

Risk management alignment (ISO 14971), Biocompatibility justification), Software documentation (if applicable) , Labeling review (21 CFR Part 801), eSTAR submission preparation

3.Provide Support for novel devices without predicate

Cover Letter, Risk classification strategy, Clinical evidence planning, Special controls proposal drafting, Full De Novo dossier compilation

4.Pre- Market Approval Support - For Class III

Clinical trial strategy, IDE workflow support, PMA module compilation

5.FDA Q-Submission