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De Novo Pathways. 510(k) Clearance. Appropriate when your device is ... Do all Medical Startups need FDA approval or clearance? No. Whether you need ...
AI diabetic retinopathy screening tools and their FDA clearances; Home monitoring devices (e.g., home OCT prototypes, smartphone-based visual acuity tools) ...
Medical device classification: Some diagnostic or decision-support tools may require regulatory clearance (e.g., FDA, CE mark). ... IRB approval (if framed as ...