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Home » Store » Books » Device Accessories: Understanding and Implementing FDA’s Guidance

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Device Accessories: Understanding and Implementing FDA’s Guidance

$177.00
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Product Details

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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PDF Edition

 

Available Format

PDF Edition — $177

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

Multi-user Access

Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

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Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.

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