On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
1/13/2025
/ Artificial Intelligence ,
Cybersecurity ,
Data Management ,
Data Protection ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Popular ,
Regulatory Requirements ,
Risk Assessment ,
Software
On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more
3/26/2024
/ Artificial Intelligence ,
CDRH ,
Center for Biological Diversity ,
Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Popular ,
Public Health ,
Shareholders ,
White Papers
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”). The Final Guidance replaces...more
10/11/2023
/ Artificial Intelligence ,
Cybersecurity ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) ,
Machine Learning ,
Medical Devices ,
NTIA ,
Popular ,
Premarket Approval Applications ,
Risk Management ,
Software ,
Source Code
On September 29, 2022, the United States Government Accountability Office (“GAO”) and the National Academy of Medicine (“NAM”) jointly published a detailed Report to Congressional Requesters titled Artificial Intelligence in...more
On April 8, 2022, FDA issued new, long-awaited draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (Draft Cybersecurity Guidance). 1 This draft guidance...more
The International Electrotechnical Commission (IEC) and the International Organization for Standards (ISO) recently published a cybersecurity standard that has received limited press but may have a significant impact on...more