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FDA can now reject new medical devices over cyber standards
March 29, 2023, 9:09 p.m. |
The Record by Recorded Future therecord.media
The Food and Drug Administration [affirmed](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-refuse-accept-policy-cyber-devices-and-related-systems-under-section) Wednesday that medical device manufacturers must now prove their products meet certain cybersecurity standards in order to get the agency’s approval. The guidelines were laid out in the omnibus appropriations bill signed into law last December, which authorized the FDA to impose security requirements on manufacturers and allocated $5
briefs cyber devices fda medical medical devices reject standards technology
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