The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30 th pertaining to the enhanced drug distribution security requirements under the Drug Supply ...
With healthcare cyber attacks on the rise, the Food and Drug Administration is shifting its concern to a largely untargeted, yet vulnerable, area: medical devices. Here are six things to know. 1. The ...
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). 1 The ...
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