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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:
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- The definition of accessory and parent device from the guidance
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- How the definition applies to “software as a medical device” (SaMD)
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- The three-pronged approach to application of the accessory definition
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- How to determine the classification status of an accessory
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- The two methods of change applicable to a classified accessory
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- The use of the de novo application process for an unclassified accessory
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BONUS: You’ll receive a worksheet to help apply the definitions and determine if the accessory is classified.
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PDF Edition
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Available Format |
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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
- Production Managers
- Product Documentation Specialists
- Risk Management Specialists
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Our Guarantee
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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