FDAnews Announces — Medical Device Recall or Product Enhancement?: Understanding When to Submit a Part 806 Webinar, June 5, 2014

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. This webinar explains the differences on how current or future product enhancements might be viewed by FDA.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) May 28, 2014

Medical Device Recall or Product Enhancement?:
Understanding When to Submit a Part 806
**FDAnews Webinar**
June 5, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/DeviceRecall

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 current or future product enhancements might be viewed by FDA? This webinar 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In 2013 the FDA issued draft guidance (Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements) to explain when a product enhancement is really just a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 a product fails any of these tests manufacturers 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 manufacturers make any product enhancements intended to reduce a risk to health, even if the reason is human error, then the company has committed a recall.

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

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

Join FDAnews on June 5 for keys to unlocking a savvy balance between the FDA’s expectations and current product enhancement activities. Every change or enhancement made could be under scrutiny.

FDAnews has teamed up with noted recall specialists Neil O’Flaherty and Evan Phelps of Olsson Frank Weeda Terman Matz to clear up the confusion.

Meet the 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.

Evan Phelps, Principal Attorney , OFLW Law advises companies on compliance with FDA law and regulations, with focus on matters related to medical devices and biologics as well as those affecting clinical investigators.

Who Will Benefit:

  •     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    

Conference Details:
Medical Device Recall or Product Enhancement?:
Understanding When to Submit a Part 806
**FDAnews Webinar**
June 5, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/DeviceRecall

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/DeviceRecall
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.