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# Bill Introduced for Streamlined Device Accessory Classification
- URL: https://www.fdaweb.com/bill-introduced-for-streamlined-device-accessory-classification/
- Published: 2017-04-26T12:00:00.000Z
- Updated: 2026-09-14T22:20:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138545

Reps. **Ann Kuster** (D-NH) and **Mimi Walters** (R-CA) have introduced [HR 2144](https://www.congress.gov/bill/115th-congress/house-bill/2144?q=%7B%22search%22%3A%5B%22HR+2144%22%5D%7D&r=1&ref=fdaweb.com) that would require FDA to implement an efficient, streamlined process for classifying medical device accessories. In announcing support for the measure, the Advanced Medical Technology Association (AdvaMed) said it would “establish a new procedural mechanism for accessory classification, based on the sponsor’s recommendation supported by relevant data and information. The bill also would allow the agency to efficiently re-classify accessories currently on the market that are subject to an inappropriate risk classification.”

  
AdvaMed noted that the recently passed 21st Century Cures Act included a provision directing FDA to classify a device accessory independent of its parent device, “which corrected a long-standing deficiency in the agency’s review process that led to many accessories being unfairly subject to higher-risk classification than was necessary for their safe and effective use. However, FDA does not have a good mechanism for implementing this provision or for addressing the hundreds of accessories currently on the market which may be inappropriately classified... A tailored review approach for device accessories would improve FDA’s efficiency and save the agency resources while ensuring patients continue to benefit from safe and effective medical technologies.”