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Best Practices for Medical Device Reporting (MDR) Under FDA’s Final Guidance



 
Our Price: $395.00

Product Code: WB-7237
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About the Product
Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.


On November 8, 2016, FDA released its long-awaited final guidance document, “Medical Device Reporting for Manufacturers” (Final Guidance), which explains and clarifies FDA’s interpretations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping for manufacturers. The Final Guidance supersedes the Medical Device Reporting for Manufacturers final guidance published in March 1997, and replaces FDA’s draft guidance on Medical Device Reporting for Manufacturers published on July 9, 2013. The Final Guidance contains significant policy changes that will affect how device manufacturers carry out their MDR reporting obligations. This webinar will:
  • Provide an overview of the key provisions of the Final Guidance and their impact on manufacturers’ MDR reporting practices.
  • Discuss current FDA enforcement trends in the area of MDR reporting.
  • Recommend steps that manufacturers can take to avoid common MDR reporting pitfalls.
  • Provide an overview of FDA’s final regulation on safety reporting for combination products, and discuss the relationship between that regulation and FDA’s Final Guidance on MDR reporting.



Speakers:

Pamela F. Forrest
Partner
Covington & Burling LLP

Scott D. Danzis
Partner
Covington & Burling LLP


Participants that will find this webinar most beneficial will be those involved in pharmaceutical companies. Job titles of attendees that will be most applicable for this session will be:

  • Pricing
  • Government Affairs
  • Managed Markets

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