FDA Will No Longer Regulate Certain Medical Software
The US agency published a final rule on 16 April that says eight medical software functions will no longer be classified as medical devices. The rule finalizes a statutory provision from the 21st Century Cures Act.
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Digital Health Roundup, April 2021: Digital Transformation In OR, Clinical Trials, Remote Monitoring
In this new roundup feature focusing on the most notable developments in digital health, we pick the key news from April.
The Senate approved the same 21st Century Cures bill passed by the House last week on a 94-5 tally; the bill is expected to be quickly signed by President Obama. Provisions for extra dollars for FDA in the bill means that even with a plan by Congress to adopt a continuing resolution this week freezing FDA funding until April 28, the agency can rely on an additional $20 million set aside for it in Cures in the new year.
Regulators say that despite millions of HIV viral load monitoring tests on the market over the past 25 years, there has only been on class II recall for the products, which warrants easing their path to market.