FDA Compliance - EmCyte Concentrating Kits
Recently, the FDA issued a new letter “Advancing the Development of Safe and Effective Regenerative Medicine Products” by Peter Marks MD PhD, the Director for the Center for Biologics Evaluation and Research. This letter may have triggered some questions regarding the FDA’s intent to enforce their regulations for human cell, tissue, and cellular and tissue-based products (HCT/Ps).
As a clinician using the EmCyte concentrating system, rest assured that using these products is well within your scope of practice and not subject to the above referenced letter. In fact, on Page 22 of the FDA issued guidance document, which we encourage you to read, it specifically states that PRP is not an HCT/P as it is a blood product. Therefore, PRP is outside the scope of this FDA guidance.
The following define the product types that are being referenced in the issued letter and how EmCyte products are positioned and regulated through the FDA system:
Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/Ps) are human cell, tissue and cellular and tissue-based products that are manufactured by a foreign or domestic establishment that is registered with the FDA as a Tissue Establishment. These tissue establishment manufacturers (more commonly known as tissue banks) are regulated solely under section 361 of the Public Health Service (PHS) Act and are required to register and list their HCT/Ps with the Food and Drug Administration (FDA) pursuant to 21 CFR part 1271.
Regenerative Medicine Therapies (RMTs) is established in section 506(g)(8) of the Food Drug & Cosmetic Act as a drug defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act (42 U.S.C. 264) and Title 21 of the Code of Federal Regulations Part 1271 (21 CFR Part 1271). These drugs are intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition. As described in Section 3033 of the 21st Century Cures Act, these drugs are eligible for a Regenerative Medicine Advanced Therapy (RMAT) designation after an FDA submission of an Investigational New Drug (IND) application.
As EmCyte Concentrating systems are not considered drugs or a regenerative medicine therapy (RMATs), they are also not subject to Regenerative Medicine Advanced Therapy designation.
EmCyte is NOT an HCT/P manufacturer and therefore is outside the scope of 21 CFR part 1271 regulations.
EmCyte Concentrating systems are Class II products cleared by the FDA under the 510(k) premarket notification pathway for its indicated use.
As a Plymouth Medical customer, you can be certain that any product and training provided to you has been extensively vetted for compliance and evidence-based practices. In addition, our trainings continue to be supported by our ever evolving Education Portal.
Please contact our Clinical Education Team if you have any further questions or would like further clarification: education@plymouthmedical.com or (888) 392-5076 Ext 3.
06/01/21