Expert guidance on 510(k), De Novo, PMA submissions, and 21 CFR compliance. Written to help medical device companies navigate FDA regulatory pathways with confidence.
**Summary:** FDA classifies medical devices into three risk-based categories that determine the regulatory pathway (510(k), De Novo, or PMA) and oversight required. Correct classification is critical—wrong classification can delay market entry by 12–18 months or trigger enforcement action.
**FDA regulates Software as a Medical Device (SaMD)—software performing medical functions independently on general-purpose platforms like smartphones or cloud servers—under a risk-based framework, with exclusions for administrative tools, wellness apps, and clinical decision support meeting strict criteria. Companies must navigate multiple regulatory instruments including FDA's 2019 AI/ML guidance and 2023 predetermined change control plan guidance to determine premarket clearance requirements.**