Webinar On DeNovo Classification Process

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

Quality Personnel

Clinical Personnel

Research Personnel

Laboratory Personnel

Manufacturing Personnel

Legal Personnel

Clinical Research Associates

Personnel who require a general understanding of the FDA’s DeNovo Classification Process

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candle brook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support: 416-915-4458 
Email: support@compliancetrainings.com

For more information about this event please visit

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