FDA Unveils Plan for 'Software as a Medical Device' Review

2018-04-27 21:17

Agency Says It Would Assess Vendors' 'Cybersecurity Responsibility'The FDA is proposing to pre-certify vendors of certain medical device software, including various mobile apps, allowing the companies to skip the agency's much more rigorous pre-market approval process for hardware-based medical devices.

News URL

https://www.inforisktoday.com/fda-unveils-plan-for-software-as-medical-device-review-a-10925

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