Understanding and Implementing FDA’s Guidance

FDAnews

Device Accessories:

Understanding and Implementing FDA’s Guidance

**An FDAnews Brief**

http://www.fdanews.com/deviceaccessoriesbrief        

The 21st Century Cures Act requires the FDA to classify accessories.

But, what does the FDA consider an accessory?

Device Accessories: Understanding and Implementing FDA’s Guidance explains the guidance document and gives manufacturers the tools needed to determine and document whether any of their products are a device accessory. Readers will learn:


  •     The definition of accessory and parent device from the guidance
  •     How the definition applies to “software as a medical device” (SaMD)
  •     The three-pronged approach to application of the accessory definition
  •     How to determine the classification status of an accessory
  •     The two methods of change applicable to a classified accessory
  •     The use of the de novo application process for an unclassified accessory

The brief includes a worksheet to help apply the definitions and determine if the accessory is classified.

Who Will Benefit:

Determining whether a product is an accessory requires a team to cover the various aspects in making the determination. Team members include:

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

FDAnews Brief Details:

Device Accessories:

Understanding and Implementing FDA’s Guidance

Price: $177

http://www.fdanews.com/deviceaccessoriesbrief        

Easy Ways to Order:

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