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The QMN Weekly Bulletin

House Bill Would Streamline Device Accessory Approval

May 12, 2017

The FDA lacks a good mechanism for dealing with the hundreds of device accessories currently on the market which may be inappropriately classified, and a new House bill proposes to streamline the process.

The bipartisan Risk Based Classification of Accessories Act would require the FDA to revise regulations for the reclassification of previously approved, low-risk medical devices.

Currently, an accessory like a plastic tray packaged with a medical device is required to comply with the same onerous regulations as medical technology like artificial heart valves, said Rep. Annie Kuster (D-N.H.), who introduced the bill with Rep. Mimi Walters (R.-Calif.).

The bill would clarify that “something like a plastic tray doesn’t need to be tested to the same degree as a high-powered eye surgery laser,” Walters said. Some of the largest drivers of health care costs are the “antiquated, one-size-fits all regulations that make medical devices and new technologies more expensive to bring to market,” she said. It is commonsense that an accessory that does not impact the safety of a device should not need to go through the cumbersome process for FDA approval required for a more sophisticated medical device, Kuster said.

The proposed bill would create an efficient process at FDA for classifying medical device accessories, according to AdvaMed President and CEO Scott Whitaker.

The 21st Century Cures Act included a provision directing the 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, he said.

Order your copy of Drug or Device? How the 21st Century Cures Act Impacts Combination Products for practical advice on the newest changes in the law on combination products and a look around the corner at how sponsors of combination products should seek to position their products to ensure a least burdensome and optimal regulatory pathway.

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