U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more
1/14/2025
/ Artificial Intelligence ,
Clinical Trials ,
Data Collection ,
Data Privacy ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management
Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI technologies rapidly evolve, global regulators face the complex task of regulating AI to...more
The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which advises medical device manufacturers on...more
The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more...more
On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical Device Cybersecurity" (IMDRF...more
10/10/2019
/ Cybersecurity ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
International Medical Device Regulators Forum (IMDRF) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Network Security ,
Pharmaceutical Industry ,
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Regulatory Oversight ,
Vulnerability Assessments
On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"(premarket cybersecurity guidance). This coincided...more
With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical Device Safety Action Plan (the Plan)...more
4/26/2018
/ Connected Items ,
Cybersecurity ,
Data Breach ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Patient Safety ,
Personal Data ,
Pharmaceutical Industry ,
Popular ,
Regulatory Standards ,
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