FDAnews Announces — Device Accessories – Understanding and Implementing the Final Guidance Webinar, March 23, 2017

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Under the Food, Drug and Cosmetics Act (FD&CA) an accessory to a device is, itself, a device. But, it does not distinguish between accessories and other devices.

FDAnews

FDAnews

Device Accessories – Understanding and Implementing the Final Guidance
**An FDAnews Webinar**
March 23, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/deviceaccessories            

Under the Food, Drug and Cosmetics Act (FD&CA) an accessory to a device is, itself, a device. But, it does not distinguish between accessories and other devices.

Manufacturers are struggling to figure out how to classify their device accessories.

On March 23, expert, Dan O’Leary, walks attendees through the final guidance issued on Dec. 30, 2016 to describe accessories and — in certain cases — provide a classification pathway.

The guidance document presents three major points of discussion:

1.    It describes what FDA considers as an accessory
2.    It explains how to apply the device classification system to accessories
3.    It covers issues of classification and reclassification with particular emphasis on using the de novo process for accessories not already classified.

Register today and learn to apply the guidance document to your products to determine if any of them are an accessory and ensure they meet device regulations.

BONUS: Attendees will receive a worksheet to help apply the definitions and determine if the accessory is classified as well as a copy of the guidance document.

Meet the Presenter:
Dan O’Leary is the President of Ombu Enterprises, LLC., a company offering training and execution in Operational Excellence, focused on analytic skills; and a systems approach to operations management. Dan has more than 30 years’ experience in quality, operations and program management in regulated industries including: aviation, defense, medical devices and clinical labs. He has a Master’s Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who Will Benefit:

  •     Product Marketing Specialists
  •     Regulatory Affairs Specialists
  •     Device Quality Specialists
  •     Design Engineering Managers
  •     Production Managers
  •     Product Documentation Specialists
  •     Risk Management Specialists

Webinar Details:
Device Accessories – Understanding and Implementing the Final Guidance
**An FDAnews Webinar**
March 23, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/deviceaccessories            

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/deviceaccessories                                        
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.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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