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Legislation Would Streamline Risk-Classification For Device Accessories

A bill introduced in the US that industry stakeholders want to be added to the "must-pass" user-fee reauthorization bill would create a tailored approach to classifying or reclassifying device accessories, following up on change made last year that requires accessories to be classified separately from parent devices. Streamlining accessory oversight has been an industry goal, particularly of health-software makers.

Following provisions in the 21st Century Cures Act to separate US FDA review of accessories from their parent device, a bill proposed in the US House would create a new streamlined regulatory pathway for accessories. The bill is being hailed by industry lobbyists as an "important legislation" that would save the agency resources while stopping regulators from unfairly categorizing the products.

Device-industry advocates hope to add the legislation, which was introduced in the House and referred to the House Energy and Commerce Committee on April 25, to the medical device user fee reauthorization bill, or MDUFA IV, which is currently moving through Congress and must pass by July to avoid layoff-planning notices to go out to FDA employees

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