Organs, tissues, and medical devices are regulated very differently

 Here's an article in JAMA by a Michigan doctor and his Congresswoman, on the lack of regulation for some substances of human origin.

Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue–Based Products, by Robert P. Dickson, MD; Deborah A. Dingell, MS, JAMA. 2024;331(20):1703-1704. doi:10.1001/jama.2024.6834

" In 2021, an outbreak of M tuberculosis occurred in the US when contaminated bone graft material was implanted into 113 patients, 77% of whom developed clinically apparent tuberculosis.

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[Again in 2023] "the Centers for Disease Control and Prevention (CDC) had identified additional tuberculosis-infected patients who had received implants of the same product, harvested from the same donor. At final count, 36 patients in 7 states had undergone implantation of bone graft tissue contaminated with M tuberculosis.

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"Given the rigorous safety testing required of most medical therapies, how could 2 lethal outbreaks of tuberculosis occur in as many years, arising from the same product, distributed by the same company?

"The answer lies in the FDA’s designation of this product as a human cells, tissues, and cellular and tissue–based product (HCT/P) (Table). This class of therapies, which includes bone grafts, skin grafts, and stem cells, is not subject to the same regulatory standards as pharmaceuticals, biological products (such as blood products and monoclonal antibodies), or organ transplants. This designation has profound regulatory and clinical consequences