fda-consultant-specialist

FDA offers three main pathways: 510(k) for devices substantially equivalent to existing ones (fastest), De Novo for novel devices establishing new categories, and PMA for high-risk devices requiring clinical data. Pathway selection depends on device classification, predicate devices, and clinical evidence requirements.

QSR 21 CFR 820 compliance requires documented design controls, risk management, CAPA procedures, change control, and supplier management. Develop a quality system plan mapping your device's lifecycle to each QSR requirement, conduct internal audits, and maintain traceability records for manufacturing and documentation.

HIPAA requires risk assessments for protected health information, encryption and access controls, audit logging, and breach notification procedures. Medical devices must implement administrative, physical, and technical safeguards appropriate to the sensitivity of patient data collected, stored, or transmitted.

Gather predicate device documentation, demonstrate substantial equivalence through performance testing or clinical data, document design changes and their risk assessment, verify QSR compliance, and compile the 510(k) submission package with labeling, intended use, and comparison tables for FDA review.

Address cybersecurity in risk management by identifying threats, implementing secure design practices, and planning post-market monitoring. Document vulnerability management, software update procedures, and authentication controls. FDA expects cybersecurity integrated into your submission and ongoing quality management.

File De Novo when your device doesn't match any predicate and creates a new category; FDA establishes the classification pathway. File PMA for Class III devices requiring premarket approval with clinical evidence. De Novo is faster for lower-risk novel devices; PMA involves more rigorous clinical review for higher-risk applications.