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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance.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.

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China plans to strengthen lithium battery industry regulations

JURIST

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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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law Blog

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions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 The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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Draft Guidance on Biosimilars and Interchangeables Tries to Smooth Path for Post-Approval Changes

FDA Law Blog

In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. Biosimilar and interchangeable sponsors with moderate post-manufacturing changes can submit a Change Being Effected in 30 Days (CBE-30) supplement.

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FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

FDA Law Blog

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.

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LegalOn Expands from Contract Review to Drafting with Addition of 100+ Lawyer-Drafted Contract Templates

LawSites

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. ”