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.
You may also be interested in...
President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.
House Energy and Commerce Committee members added a slate of industry-favored device amendments into the FDA Reauthorization Act before sending the bill to the chamber floor, including reforms targeting device accessories, medical imaging and post-market surveillance.
In a podcast interview to discuss his initial experience as chairman of AdvaMed, CVRx CEO Nadim Yared talks about the group's laser focus on device-tax repeal, irrespective of broader GOP health-care debates and controversy, its capacity to handle unpredictability and change in Washington, DC, and more.