Device Accessories – Understanding and Implementing the Final Guidance - Webinar CD/Transcript

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Device Accessories – Understanding and Implementing the Final Guidance

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.

On Dec. 30, 2016, the FDA-CDRH+CBER issued a final guidance document to describe accessories and — in certain cases — provide a classification pathway.

The guidance describes and defines what the FDA considers an accessory with a three-prong performance determination including: to support, supplement or augment a parent device.

Dan O’Leary explains the approach in the guidance document and gives you the tools you need to determine and document whether any of your products are an accessory.

After this 90-minute session you’ll:

  • Learn the definition of an accessory and parent device from the guidance document — they are not in any regulations
  • Understand how the definition applies to “software as a medical device”
  • Understand the three prong approach to application of the accessory definition
  • Learn how to determine the classification status of an accessory
  • Understand the two methods of change applicable to a classified accessory
  • Understand the use of the de novo process for an unclassified accessory

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

Order 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.

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

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.