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Device Accessories: Understanding and Implementing FDA’s Guidance

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Device Accessories
Understanding and Implementing FDA’s Guidance

Device Accessories: Understanding and Implementing FDA’s Guidance explains the guidance document and gives you the tools needed to determine and document whether any of your products are a device accessory.  You 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

BONUS: You’ll receive a worksheet to help apply the definitions and determine if the accessory is classified.

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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

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