FDA Law Blog
MAY 6, 2024
Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. are cybersecure.
JURIST
MAY 9, 2024
China sought to solicit public opinion towards the draft regulations , aiming at regulating its rapidly growing lithium battery industry on Wednesday. The rules, proposed by the Ministry of Industry and Information Technology, are designed to curb unchecked expansion and promote sustainable and high-quality development within the sector.
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LawSites
SEPTEMBER 21, 2023
LegalOn , a company that was already one of Japan’s largest providers of AI contract review technology when it launched into the U.S. ” Read more about LegalOn in the LawNext Legal Technology Directory. . ” Read more about LegalOn in the LawNext Legal Technology Directory. ”
FDA Law Blog
FEBRUARY 9, 2024
Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. smartphones and tablets) for remote data acquisition in a clinical investigation.
FDA Law Blog
MAY 8, 2023
Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).
FDA Law Blog
OCTOBER 10, 2023
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”
FDA Law Blog
NOVEMBER 29, 2023
Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions. Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change.
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