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Mark E. Brager
April 26, 2017

House Bill Would Improve Device Accessory Review Process

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker following introduction in the U.S. House of legislation (HR. 2144) designed to streamline the review process for medical device accessories:

“The recently passed 21st Century Cures Act included an important 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. The legislation introduced by Reps. Mimi Walters (R-Calif.) and Ann Kuster (D-N.H.) will address this situation by creating an efficient, streamlined process at FDA for classifying medical device accessories.

“Specifically, the legislation 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.

“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. We commend Reps. Walters and Kuster for their leadership on this issue and look forward to working with members of Congress, FDA and other key stakeholders to move this important legislation.”