The De Novo process is a complex process that has significant implications for the manufacturer of post-amendment devices in terms of how their devices are classified. In addition, the FDA has recently revised the regulations in 21 CFR part 860 that pertain to the reclassification of devices in this category. This webinar will be essential in your continued understanding of this process and in your compliance with the new regulation changes.
For devices that are innovative, when a predicate is found not to exist, The De Novo classification process, also known as “Evaluation of Automatic Class III Designation,” is a device classification process that provides a pathway to either a Class I or Class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.
This webinar will review this De Novo process in conjunction with the recent changes to 21 CFR 860 that pertain to the reclassification of these post-amendment devices and the De Novo process in general.
- The De Novo Classification Process
- When the De Novo Process may be used
- Submitting a De Novo Request for FDA Review
- Review Process for De Novo Requests
- 21 CFR 860 regulation changes as they relate to the De Novo process
- Regulatory Departments
- Manufacturing Departments
- Compliance Departments
- Documentation Departments
- Training Departments