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 — $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
Product Documentation Specialists
Risk Management Specialists
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