FDA is making a coordinated push to shine light on appropriate regulatory pathways for the fledgling industry focused on developing products made with human cell or tissue components. It is planning an April public meeting to discuss the product category and four recently issued draft guidance documents addressing the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps).

The public meeting is set for April 13, 2016, at FDA’s Silver Spring, Md., headquarters. FDA wants to gather feedback on the draft guidances from industry, academia and other stakeholders. The agency says it is looking for “comments on the scope of each guidance, including the particular topics covered, the particular questions posed, whether there are additional issues for which they seek guidance, and whether FDA’s recommendations for each topic are sufficiently clear and consistent within and across documents to provide meaningful guidance to stakeholders. In addition, FDA welcomes any comments that will enhance the usefulness and clarity of these documents.”

The guidance documents address different elements of the regulatory framework for HCT/Ps. One draft, issued Oct. 23, 2014, addresses the “same surgical procedure” exemption that says FDA will not regulate cells or tissues that are removed from a patient and transplanted back into that patient during a single procedure. Another two were issued Dec. 24, 2014, one describing the term minimal manipulation of human cells, tissues, and cellular and tissue-based products and the other discussing regulation of human cells, tissues, and cellular and tissue-based products from adipose tissue. A draft guidance on homologous use of human cells, tissues, and cellular and tissue-based products was issued concurrently with the meeting announcement on Oct. 29. Comment periods on the first three guidances have been reopened, with the new comment periods for all four documents set to last until April 29, 2016.

FDA regulates HCT/Ps under Public Health Service authority via a risk-based approach, as long as the HCT/Ps are minimally manipulated and the cells or tissues are not be combined with another article unless the article is water, crystalloids, or a preservation, sterilization or storage agent known to be safe. In addition, the HCT/P must be intended for homologous use and must either not have a systemic approach, or, if it does have a systemic approach, must be autologous, allogeneic or reproductive. Products falling outside those guidelines are regulated as drugs or devices.

New Draft Guidance on Homologous Use

The new guidance document, “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products,” was jointly issued by the agency’s device and biologics centers. It says that for the purpose of HCT/P regulation, homologous use means “the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.” For example, transplanting a new heart valve to replace a defective one is homologous use, as is using pericardium as a wound covering for dura mater defects because one of the functions of pericardium is to act as a covering. It is not necessary the transplanted tissue be placed in the same spot on a recipient as it was on the donor as long as the basic function is the same, FDA notes.

The guidance goes on to define terms including: repair, reconstruction, replacement and supplementation. Specifically, repair means restoring tissues, including by covering or protecting them. Reconstruction, on the other hand, means surgical reassembly or reformation. Replacement is using a new product to substitute for a damaged body part, while supplementation is adding to a body part, as in wrinkle fill injections.

If an HCT/P is intended and approved for homologous use, the marketing materials – including written and oral statements – should refer only to those functions, FDA warns.

FDA Aims To Clarify Human Cell/Tissue Regulation With Upcoming Meeting, Guidance Documents

More from Regulation

More from Policy & Regulation