The targeted FDA Device Accountability Act mirrors select device sections of the House 21st Century Cures legislation seeking to strengthen the use of "least-burdensome" provisions, allow use of centralized IRBs for device trials and refining standards for diagnostic CLIA waivers.
The Senate has yet to release a broad-based medical products reform bill to parallel the rapidly moving "21st Century Cures" legislation in the House, but individual medical device reform provisions are surfacing in the upper chamber, including the FDA Device Accountability Act introduced June 18.
The bill, sponsored by Republican Sen. Richard Burr (N.C.) and Democratic Sen. Al Franken (Minn
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A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
