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 Covered in the Session :
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
Single Live : For One Participant
Corporate Live : For Max. 10 Participants
Single REC : For One Participant - Unlimited Access for 6 Months
For more information and enquiries contact us at
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