Compliance, FDA and State Policy - Health Care Compliance Brief

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FDA Issues Final Guidance on Communications About Unapproved Uses of Medical Products

Hall Render

JANUARY 30, 2025

This guidance finalizes FDAs revised draft issued in October 2023 , which updated and replaced the 2014 and 2009 draft guidance documents. A statement disclosing FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling. Before the U.S.

FDA

FDA State Policy Public Health Compliance

Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

Compliance

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FDA Issues Final Guidance on Communications About Unapproved Uses of Medical Products

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