ComplianceOnline

Webinar Transcript - Off-Label Promotion of Medical Devices Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices


Provider: ComplianceOnline
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The transcript of the webinar “ Off-Label Promotion of Medical Devices Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices ” conducted by ComplianceOnline describes critical issues that arise in the advertising and promotion of medical devices. Further, the transcript will help the readers understand what constitutes valid scientific evidence to support advertising and promotional claims.

You will learn about:

  • The critical issues that arise in advertising and promotion of medical devices.
  • What constitutes valid scientific evidence to support advertising and promotional claims.
  • What are the rules and regulations for off-label use of medical devices.
  • What types of promotional claims go too far and run the risk of generating a Warning Letter from FDA.
  • What data are necessary to compare your product to a competitor's product.
  • Examples of punitive enforcement actions.
  • Why FDA may now be holding medical device manufacturers to a higher standard than previously, especially regarding misleading claims and off-label use.

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