On December 29, 2022, the president of the United States signed into law the Food and Drug Omnibus Reform Act of 2022 (FDORA) as part of the Consolidated Appropriations Act, 2023.
This law introduces various provisions aimed at improving medical device cybersecurity, which will have considerable effects on medical device manufacturers and their consumers. Through FDORA, the United States Food and Drug Administration (FDA) was granted the legislative authority to require cybersecurity documentation from medical device manufacturers.
Ken Zalevsky, Vigilant Ops Chief Executive Officer, dives into FDORA’s pivotal role in shaping medical device cybersecurity in the Winter 2024, Vol. 19, No. 1 issue of USNC (U.S. National Committee of the IEC, a committee of the American National Standards Institute) Current.
