What is U.S. FDA CGMP expectations / requirements for Post Market Surveillance and Complaint Handling.
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 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".
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
