Navigating the complexities of FDA's ACNU pathway and SaMD regulations requires meticulous planning. Is your team ready?
Clearly articulate the intended use, target patient population, dosage (if applicable), and proposed OTC labeling/digital interface for the ACNU or SaMD product.
ACNU: Confirm the product requires conditions beyond labeling for safe OTC use. Map requirements to potential ACNU implementations (digital screener, education module). SaMD: Determine the IMDRF risk classification (I-IV) based on intended use and potential harm. Identify the likely FDA submission pathway (510(k), De Novo, PMA).
Outline the necessary studies (Label Comprehension, Self-Selection, Actual Use, Usability/Human Factors) required to demonstrate safe and effective use without clinician oversight.
Define the target retail channels (pharmacy, e-commerce, kiosks), pricing model, and integration requirements for verification and fulfillment.
Identify leads from Regulatory Affairs, Clinical, Digital/IT, Commercial, Quality Assurance, and Legal. Establish clear roles and responsibilities.
Develop a realistic budget and project timeline, accounting for regulatory review periods, software development, and validation efforts.
Choose between building in-house vs. using a dedicated platform (like Aegis). Ensure the chosen architecture supports: Multi-channel delivery (Web, Mobile), Scalability for national/global launch, High availability (target 99.9%+ uptime).
Implement 21 CFR Part 11 compliant audit trails, electronic signatures, and data integrity controls. Establish SOC 2 Type II and ISO 27001 security frameworks.
Build or configure APIs for retail POS systems, e-commerce platforms, and pharmacy management systems. Ensure secure data exchange and real-time verification.
Implement ISO 13485 compliant QMS for SaMD. Establish document control, change management, and CAPA processes.
Complete software development lifecycle documentation. Perform verification and validation testing. Establish traceability matrix linking requirements to tests.
Conduct formative and summative usability studies. Identify and mitigate use-related risks. Document user interface design rationale.
Execute Label Comprehension, Self-Selection, and Actual Use studies. Collect and analyze data to demonstrate safe OTC use. Prepare clinical study reports for FDA submission.
Perform threat modeling and risk assessment. Implement security controls and encryption. Establish vulnerability management and incident response procedures.
Compile comprehensive submission (NDA supplement for ACNU, 510(k)/De Novo for SaMD). Include all validation documentation, clinical data, and labeling. Prepare responses to anticipated FDA questions.
Establish real-world evidence collection mechanisms. Implement adverse event reporting (MedWatch). Set up ongoing safety monitoring and periodic reporting.
Train retail partners and pharmacy staff. Deploy marketing and consumer education materials. Activate customer support and technical assistance channels.
Monitor system performance and user feedback. Implement software updates and enhancements. Maintain regulatory compliance through lifecycle management.