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Guidance on Device Changes: When to Submit a 510(k)

The talk covers device changes and their regulatory implications using FDA guidance. It focuses on two key documents for deciding when a 510(k) submission is needed for hardware and software changes. A "letter to file" process is used for post-market evaluations, while the guidance also helps in pre-market strategies for anticipating design changes that may require a 510(k). #510kSubmission #MedicalDevices #FDA510k #Innolitics #healthcarecompliance Key Takeaways FDA guidance emphasizes a risk-based approach, focusing on safety, effectiveness, and thorough documentation. Software changes, especially new features, may trigger 510(k) submissions, requiring clear justification. Comprehensive documentation is crucial for compliance, even if changes don’t require a 510(k) submission. Special 510(k) submissions offer faster FDA review within 30 days with less documentation. Collaboration between engineering and regulatory teams is key to reducing uncertainty in FDA submissions. Participants J. David Giese - President, Partner Yujan Shrestha - CEO, Partner Mary Vater - Director of Regulatory Affairs Reece Steven - Director of Engineering Joshua Tzucker - Senior Software Engineer Pablo H. Cerdan - Software Engineer, AI/ML George Hattub - Director Device Regulatory Affairs Specialist 00:00 Introduction 03:39 Key principles 07:36 How to use the Guidance Documents 09:49 How does that relate to a PCCP? 12:37 Main flowchart 14:29 Labeling changes 16:58 Technology and performance 17:56 Technology and performance Flowchart 18:18 Materials 18:27 Software change evaluation flowchart 21:31 Additional Software factors that may influence decision to file 22:42 Key Decision Points and Risks in Implementing Software Changes: Insights from Real-World Experiences with DICOM and PET CT Integration 27:34 Navigating Regulatory Risk: Weighing New Features, Operating Principles, and the 510(K) Submission in Software for Medical Devices 32:20 Balancing Client Pressure and Regulatory Compliance: The Challenges of Letters to File in FDA Oversight 35:59 Navigating Software Changes and Risk Assessment: Key Considerations for FDA Submissions 38:39 Handling Multiple Changes in 510(k) Submissions: Challenges and Documentation Considerations 40:28 Leveraging Special 510(k) for Faster FDA Review: Timelines, Strategies, and Considerations 43:40 Navigating Regulatory Challenges: Balancing Conservatism and Business Needs in Medical Device Companies