jueves, 18 de enero de 2024
CDRH 2023 Annual Report
https://www.fda.gov/about-fda/cdrh-reports/cdrh-2023-annual-report?utm_medium=email&utm_source=govdelivery
2023 was a transformative year at the FDA’s Center for Devices and Radiological Health (CDRH). The Center officially turned a corner on the COVID-19 pandemic and moved toward a more sustainable workload, including prioritizing normal review timelines for all incoming premarket submissions. In 2023, CDRH authorized the highest number of novel medical devices on record (excluding EUAs).
Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity
https://www.imdrf.org/documents/principles-and-practices-software-bill-materials-medical-device-cybersecurity?utm_medium=email&utm_source=govdelivery
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