{"id":9867,"date":"2022-01-23T23:10:38","date_gmt":"2022-01-23T23:10:38","guid":{"rendered":"https:\/\/usleadnetwork.net\/phwellness\/?p=9867"},"modified":"2022-01-23T23:10:38","modified_gmt":"2022-01-23T23:10:38","slug":"overview-of-fda-regulations-on-human-cell-and-tissue-based-products-351-vs-361-classification","status":"publish","type":"post","link":"https:\/\/usleadnetwork.net\/phwellness\/overview-of-fda-regulations-on-human-cell-and-tissue-based-products-351-vs-361-classification\/","title":{"rendered":"Overview of FDA Regulations on Human Cell and Tissue Based Products: 351 vs. 361 Classification"},"content":{"rendered":"

\"FDADisclaimer: I\u2019m not an attorney, this is not legal advice.<\/p>\n

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Overview<\/span><\/strong><\/p>\n

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With the exponential increase in the United States for regenerative procedures over the past decade, there has also been a major rise in regulatory questions. These questions revolve around autologous vs allogeneic regulations, cellular vs acellular and whether or not full FDA approval is required for marketing and\/or usage of products.<\/span><\/p>\n

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In July of 2020, the FDA published a Regulatory handbook in an attempt to address a lot of the questions. Unfortunately, many industry competitors such as sales reps and company owners <\/span>have either not read the handbook, or just decided to disseminate false information about the regulations.<\/span><\/p>\n

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Here’s the header of the handbook:<\/span><\/p>\n

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FDA Responsibility<\/strong><\/span><\/p>\n

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Hopefully this article <\/strong>will clear up how these tissues are actually regulated. The USA FDA has jurisdiction in America over human and veterinary drugs, biological\/tissue products and medical devices. The goal is to ensure the highest level of safety, effectiveness and security possible for these as well as the nation\u2019s food supply and cosmetics too.<\/span><\/p>\n

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While the FDA regulates drugs, biologics, tissues and devices from a manufacturing and marketing perspective, they do NOT regulate the practice of medicine in the USA. A lot of people do not realize that. That responsibility lies with each state\u2019s medical board.<\/span><\/p>\n

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When a medical provider is sitting in a consultation with a patient, and a decision is made to use a technology for treatment, the FDA has nothing to do with that conversation.<\/span><\/p>\n

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Autologous vs Allogeneic<\/span><\/strong><\/p>\n

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If a medical provider performs a procedure using a patient\u2019s own bone marrow or adipose tissue, and then delivers that tissue back to the patient, that is an autologous procedure. If a medical provider uses tissue from a donor to place into a patient, that is an allogeneic procedure.<\/span><\/p>\n

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Interestingly, the FDA in America tries to look at these tissues with the same set of regulations.  While some providers have looked at autologous procedures as being a \u201cfree for all\u201d with how they are used, that is not the case! Having one set of regulations has leveled the playing field between usage.<\/span><\/p>\n

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FDA\u2019s Categorizations 351 vs 361<\/strong><\/span><\/p>\n

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These FDA regulations place tissue into one of two categories under the Public Health Service Act, which is part of the Code of Federal Regulations Part 1271. The division of the FDA tasked with the regulatory authority is known as CBER, which stands for Center for Biologics Evaluation and Research. They have separated tissues and biologics into two categories, either as a 351 or a 361 designation.\"\"<\/span><\/p>\n

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If a tissue is designated as a 351 product, then it falls into the drug\/biologics pathway. This means it  requires a series of Clinical Trials to obtain full FDA Approval for usage. Just like a drug, once the biologic is approved it will then be approved for marketing for a specific therapeutic use. Any other use would be considered \u201coff label\u201d. \u201cOff label\u201d usage is very common in the USA.<\/span><\/p>\n

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Now let\u2019s discuss the 361 designation. In the July 2020 FDA Regulatory handbook, they mention that in order to qualify as a 361 tissue product, the criteria of both \u201cminimal manipulation\u201d and \u201chomologous use\u201d need to be met.<\/span><\/p>\n

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I\u2019ll define those specifically in a moment. If both of those criteria are met, the tissue achieves the designation of an HCT\/P. That is short for Human Cells, Tissues, and Cellular and Tissue-Based Products.<\/span><\/p>\n

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See the table below, which distinguishes the two categories.<\/span><\/p>\n

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Minimal Manipulation<\/strong><\/span><\/p>\n

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Alright so let\u2019s define Minimal Manipulation. This has to do with the methods by which the tissue is processed, whether it\u2019s autograft or allograft. Per the FDA\u2019s Regulatory handbook, minimal manipulation refers to the following:<\/span><\/p>\n

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