Bioethics, FDA and Informed Consent - Health Care Compliance Brief

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Bioethics

FDA

Informed Consent

Could Self-Operated Assisted Suicide Devices Be Coming to a Town near You?

Bill of Health

DECEMBER 20, 2022

FDA Approval. Food and Drug Administration (FDA), which “ regulates the sale of medical device products (including diagnostic tests) in the U.S. ” Although it is questionable whether the FDA would ever approve the Sarco machine as a medical device, it turns out the FDA may not need to. .”

FDA

FDA Doctors Informed Consent Bioethics

R&D Mini-Me? New Legal Questions for Organoids

Bill of Health

FEBRUARY 26, 2024

In December 2022, the FDA Modernization Act 2.0 formally ended the FDA’s 1938 mandate to use animal models and opened the doors for organoids to be used as a full replacement for animals in pre-clinical trials. Would they classify as a medical device or biologic under FDA guidelines, or perhaps as a combination product?

FDA

FDA Informed Consent Bioethics

Could Self-Operated Assisted Suicide Devices Be Coming to a Town near You?

R&D Mini-Me? New Legal Questions for Organoids

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