Objectives of the Presentation
At the completion of this webinar, participants will be able to:
Why Should you Attend
- Describe the De Novo Classification Process
- Explain when the De Novo Process may be used
- Describe the process for submitting a De Novo Request for FDA Review
- Describe each step of the review Process for De Novo Requests
- Explain the implications of the 21 CFR 860 regulation changes to the De Novo process
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.
Who will Benefit
- Regulatory Affairs/Compliance
- R & D
- Quality Engineers
- Quality Managers
- Regulatory Specialists
- Regulatory Managers
- Compliance Specialists
- Design and development engineers
- Industrial designers
- Risk managers and project managers
- Medical device manufacturers
- CEOs and operations managers for small companies
- Training associates
- Training developers
- Training managers and directors
- Compliance managers
- Compliance directors
Unlike other countries in the world, the US uses a predicate-based system to classify its medical devices. For devices that have a predicate device in the marketplace the classification process is quite straightforward.
A predicate device is a legally marketed device, called a preamendments device, that was legally marketed prior to May 28, 1976, a device which has been reclassified from Class III to Class II or I, a device which has been found to be substantially equivalent to such a device through the 510(k) process, or one established through Evaluation of Automatic Class III Definition. The legally marketed device(s) to which equivalence is drawn is known as the "predicate" device(s).
Alternatively, devices of a new type that the FDA has not previously classified based on risk are "automatically" classified into class III regardless of the level of risk they pose. This is because, by definition, a new type of device would not be within a type that was on the market before the 1976 Medical Device Amendments or that has since been classified into Class I or Class II.
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.