This proposed session focuses on practical lessons learned from FDA interactions involving software, algorithms, AI/ML, and cybersecurity in safety-critical medical devices. The webinar is targeted toward regulatory, quality, digital health, legal, and executive stakeholders involved in medical device development and commercialization. Topics include common FDA deficiencies across 510(k), De Novo, and PMA submissions; regulatory expectations for AI/ML and PCCP frameworks; software documentation and human factors issues; and cybersecurity expectations such as SBOMs, threat modeling, and postmarket management. The session emphasizes integrating regulatory strategy early in development to reduce delays and review cycles. The featured speaker, Richard Jackson, brings over 25 years of experience in safety-critical systems, AI, software validation, and FDA submissions for Class II and III medical devices.
Discussion Topics and Learning Objectives
- Identify common pitfalls observed in FDA reviews – especially of software, algorithms, and cybersecurity across 510(k), De Novo, and PMA submissions.
- Identify FDA expectations for AI/ML software models versus traditional safety critical algorithms - specifically the additional planning and testing, and the additional requirements for changes under the AI PCCP guidance.
- Recognize key deficiencies cited by FDA related to software documentation, human factors, and risk management, cybersecurity
- Apply practical strategies to align with FDA cybersecurity expectations, including SBOM, threat modeling, and postmarket management.
- Integrate regulatory considerations early into product development to reduce review cycles, deficiencies, and delays.
Who Should Attend?
- Digital Health & Software Product Leaders
- Regulatory Affairs Professionals
- Startup Founders and Executive Leadership
- Clinical Innovation and Health System Stakeholders
- Quality, Risk, and Patient Safety Leaders
- Investors, Accelerators, and Venture Advisors
Speaker
Richard Jackson
Moderator:
