Medical Device Recall or Product Enhancement?

Medical Device Recall or Product Enhancement? - Webinar CD/Transcript

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Medical Device Recall or Product Enhancement?: Understanding When to Submit a Part 806

Based on the FDA’s most recent recall guidance, devicemakers now have to wonder if their product enhancements are:

  • An acceptable product enhancement
  • A recall
  • A product enhancement that’s now considered a recall
  • Or neither a product enhancement nor a recall

Unclear on how your current or future product enhancements might be viewed by FDA? This webinar cd and transcript explains the differences.

In 2013 the FDA issued draft guidance (Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements) to explain when a product enhancement is really just a product enhancement and when a product enhancement actually qualifies as a recall.

The FDA stated that if your product fails any of these tests you need to submit a Part 806 report:

  • Fails to perform as intended or fails to meet any specification
  • Labeling that is false, misleading, or otherwise inaccurate
  • Device is out of compliance with FDA regulations

The guidance also makes clear that if you make any product enhancements intended to reduce a risk to health — even if the reason is human error — you have committed a recall.

But the determination whether an enhancement reduces a risk to health is not always easy.

So what about any enhancements you are currently making — or considering?  Are you sure they are not recalls? And if so, do you know what you need to do?

FDAnews  teamed up with noted recall specialists Neil O’Flaherty and Casper (Cap) Uldriks of Olsson Frank Weeda Terman Matz to clear up your confusion.

  • Anyone involved in recalls
  • Compliance officers
  • General/corporate counsel
  • Executive management
  • Quality assurance professionals
  • Risk management specialists
  • Outside attorneys
  • Regulatory affairs professionals
  • Department supervisors/directors    

Meet Your Presenters
Neil O’Flaherty, Principal Attorney , OFLW Law specializes in the area of FDA regulation of medical devices. He has spoken and written extensively on device-related topics. Mr. O’Flaherty’s device work has included assistance to the Health Industry Manufacturers Association, the nation’s largest trade association for the medical device industry, including assistance on device tracking, medical software, device reclassification matters and medical device reporting matters.  Mr. O’Flaherty was admitted to the Illinois State Bar in 1990 and the District of Columbia Bar in 1991. He is currently a member of the District of Columbia Bar and the Illinois and American Bar Associations. Mr. O’Flaherty is a graduate of the University of Notre Dame and the Loyola University of Chicago School of Law.

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap now works almost exclusively on medical device issues at Olsson, Frank and Weeda (OFW Law) in Washington, D.C.