This webinar provides information on FDA’s DeNovo classification process. The webinar explains how a device classified as a Class III device but has the risk level of a Class I or II device may be downclassified to its correct risk classification. The webinar will cover when the DeNovo process may be used, information contained in a DeNovo request, the 2 DeNovo pathways and FDA review process for DeNovo.
This is a must attend session for those personnel that require an understanding of the FDA’s DeNovo Classification process.
Areas to be Covered:
FDA DeNovo Classification Process
Request for DeNovo application
2 DeNovo Pathways
FDA DeNovo Review Process
Interactive Q&A Session
Who will Benefit:
Regulatory Affairs Personnel
Clinical Research Associates
Personnel who require a general understanding of the FDA’s DeNovo Classification Process