This web page provides information on FDA’s TRG Rapid Inquiry Program (TRIP), which will operate as part of FDA’s Tissue Reference Group (TRG). The TRIP will help manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), including those stakeholders that market HCT/Ps to physicians or patients (hereafter referred to collectively as regulated industry), obtain a rapid, preliminary, informal, non-binding assessment from FDA regarding how specific HCT/Ps are regulated. The TRIP is a temporary program of the TRG, effective June 12, 2019, to December 31, 2019.
HCT/Ps are defined in 21 CFR 1271.3(d) as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. Because of the unique nature of HCT/Ps, FDA proposed and in 2005 implemented a tiered, risk-based approach to the regulation of HCT/Ps. The tiered, risk-based approach is contained in a set of regulations commonly referred to as the “tissue rules.” These regulations can be found in 21 CFR Part 1271.
FDA currently provides regulated industry several ways to obtain information about the regulatory status of an HCT/P including, for example, whether an HCT/P meets the criteria in 21 CFR 1271.10(a) for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271:
- FDA’s Tissue Reference Group (TRG) provides product manufacturers and sponsors with an informal process through which they may obtain an Agency recommendation regarding the application of the criteria in 21 CFR 1271.10(a) to their HCT/P for a given indication for use.
- The Request for Designation (RFD) process may be used to obtain a formal Agency decision regarding the regulatory identity or classification of an HCT/P from FDA’s Office of Combination Products (OCP). Information on how to write an RFD is posted on the agency’s website.
- The Pre-RFD process is used to obtain preliminary feedback from OCP on the classification of an HCT/P. Information on this process may be found on the agency’s website.
In November 2017, FDA announced its comprehensive regenerative medicine framework. At that time, FDA also announced that until November 2020, the agency generally intends to exercise enforcement discretion for certain HCT/Ps, with respect to FDA’s investigational new drug application (IND) and premarket approval requirements, when the use of the product does not raise reported safety concerns or potential significant safety concerns. However, since the framework was announced, FDA has seen only modest progress by regulated industry in coming into compliance. Therefore, FDA is announcing the TRIP program of the TRG, for regulated industry to rapidly obtain a preliminary assessment from FDA as to how their HCT/Ps are appropriately regulated. As resources permit, FDA intends to provide preliminary, informal, non-binding responses within 3 business days after receiving an inquiry that contains sufficient detail for evaluation.
The TRIP provides a preliminary, informal, non-binding assessment from FDA’s TRG as to how an HCT/P appears to be appropriately regulated. Resources permitting, FDA will respond within 3 business days to each inquiry that contains sufficient detail for evaluation. (See IV., below, for information considered useful for review). Additional information may be requested from an inquirer if the initial submission is lacking sufficient detail. The TRIP is unable to provide an assessment concerning jurisdiction and applicable regulation when a submission lacks sufficient product information. FDA intends for the TRIP to be a temporary program to begin June 12, 2019, to December 31, 2019.
IV. Submission of a TRIP Request
The TRIP provides a preliminary, informal, non-binding assessment from FDA’s TRG based on evaluation of the following information, where provided:
- The manufacturer of the product, if other than requester.
- The source of the product, including whether it is autologous or allogeneic.
- A clear, step by step description of how the product is processed from the time of recovery to the point of use.
- The specific way(s) the product is to be used and route of administration.
- Description of any device or apparatus (e.g., syringe) required to deliver the HCT/P to the recipient.
Requests should be submitted for a single HCT/P for a sole intended use. If inquirers would like to receive a TRIP assessment for more than one type of HCT/P or for the same HCT/P for more than a sole intended use, the inquirer should submit a separate request for each HCT/P and each intended use.
V. How to Submit TRIP Requests
TRIP requests should be submitted electronically to the following email address: firstname.lastname@example.org. Please include “TRIP Inquiry” in the subject line of the email.
VI. FDA Response to TRIP Requests
Inquiries will be reviewed in the order they are received. As resources permit, FDA intends to respond to TRIP requests within 3 business days.
FDA intends to provide preliminary, informal, non-binding assessments as follows:
- the HCT/P appears to be appropriately regulated solely under section 361 of the Public Health Service (PHS) Act and the regulations in 21 CFR Part 1271;
- the HCT/P appears to be appropriately regulated under section 351 of the PHS Act and/or Federal Food, Drug, and Cosmetic Act, and applicable regulations, as a drug, device, or biologic;
- the product does not appear to be an HCT/P; or
- a recommendation cannot be made through the TRIP program because further discussion between the inquirer and FDA would be needed.