This seminar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as appropriate articles / Annexes of the EU's MDR, which require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. Section 522 is implemented in 21 CFR 822.
This formal postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. A more generalized post market surveillance / complaint handling is also a requirement under the device CGMPs, 21 CFR 820, -.100 - CAPA, and -.198 - Complaints. Data collected under post-market surveillance helps to address important public health questions on the safety and effectiveness of a device, often resulting in improvements in device design and manufacture. Similar requirement exist in the EU's MDR, as part of the final Clinical Phase"."
This formal postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. A more generalized post market surveillance / complaint handling is also a requirement under the device CGMPs, 21 CFR 820, -.100 - CAPA, and -.198 - Complaints. Data collected under post-market surveillance helps to address important public health questions on the safety and effectiveness of a device, often resulting in improvements in device design and manufacture. Similar requirement exist in the EU's MDR, as part of the final Clinical Phase"."
Course Content
Day 1- FDA postmarket surveillance, PAS requirements, MDRs, complaints, and CAPA
- Introduction
- Personal / course information
“Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act”, Guidance, dated October 2022
- 21 CFR 822 - Implementing Sec. 522 of the FD&C Act - The Law / Requirements - Class II and III Devices
- Break / Q&A
- PAS Requirements and PMAs
- PAS Orders
- PAS Protocols
- Interim and Final PAS Reports
- Report Evaluations
- Break / Q&A
- Medical Device Reporting / Adverse Events (MDRs)
- The Voluntary Summary Malfunction Reports
- Internal “Complaints” - NCMRs, OOS’
- External Complaint Handling
- CAPA Documentation
- CAPA Trending
- Failure investigation, risk management, human factors, cybersecurity, and project tools
- Review of Day 1 - Key Points
- Review of major Day 1 concepts and takeaways
- Failure Investigation Tools
- Root Cause Analysis - Methods and Tools
- Communication
- Reports
- CAPA Trending
- Break / Q&A
- Patient Hazard / Risk Management per ISO 14971:2019
- QMS / System Level
- File / Review (Benefit / Risk)
- Narrative / Descriptive Information
- Hazards, FTA, D-, P-, U-FME[C]A + Normal
- FDA Use / Human Factors Requirements
- Use Engineering Process - 9 stages - IEC 62366-1
- Cybersecurity Requirements
- Threat Modelling
- Post-Market Cybersecurity
- Break / Q&A
- Gantt Chart
- CPM Network Diagram
- PERT Network Diagram
- Post-Market Surveillance Usage
Speaker
John E. LincolnWho Should Attend
This course is ideal for professionals involved in the development, manufacture, and post-market activities of U.S. FDA-regulated medical devices, including:- Senior Management - overseeing compliance and product safety.
- Regulatory Affairs - ensuring adherence to FDA regulations and guidance.
- Quality Assurance (QA) - managing compliance, audits, and corrective actions.
- Production - implementing compliant processes and monitoring product quality.
- R&D and Engineering - developing new devices, combination products, line extensions, and incremental improvements.
- New product or combination product development
- Non-conformances, field complaints, and post-market issues
- Evaluating product changes in accordance with the Device History File (DHF) and Current Good Manufacturing Practices (CGMPs)
- Documenting actions to meet regulatory requirements
