Devices

Device Specificity Does Not Establish Insufficient Controls: AdvaMed

David McFarland

— 1 min read
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Commenting on an FDA proposal for classification of accessories distinct from other devices, including a proposed list of accessories suitable for Class 1, AdvaMed says that device specificity alone does not establish that general controls are insufficient. “Congress required FDA to classify each accessory based on its own risks, not on its design relationship to a parent device, and the proposed exclusion is inconsistent with FDA’s prior accessory classification,” the trade association says.

In addition to specific line-by-line comments, AdvaMed makes these general points:

  • device specificity alone does not establish general controls are insufficient;
  • Congress mandated classifying each accessory based on its own risk, not on its design relationship with a parent device;
  • the proposed exclusion is inconsistent with the agency’s prior accessory classification and the agency’s notice does not explain how it is consistent with earlier determinations.

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