Standards Development for Regenerative Medicine Therapies
Section 3036 of the 21st Century Cures Act refers to the development of standards for regenerative medicine therapies, including products designated Regenerative Medicine Advanced Therapies (RMATs). In consultation with the National Institute of Standards and Technology (NIST) and stakeholders, FDA is facilitating efforts to coordinate the development of standards for regenerative medicine therapies.
Beginning in 2017, FDA has awarded an annual contract to Nexight Group and the Standards Coordinating Body (SCB) to coordinate community efforts toward the development of standards for regenerative medicine therapies. Under these contracts, Nexight has conducted public workshops and webinars to develop processes to enable identification of needed standards and facilitated the development of standards that have a high impact on the quality and safety of regenerative medicine therapies. In addition, SCB maintains the Regenerative Medicine Standards Portal (an interactive database that displays standards applicable to regenerative medicine therapies and the status of these standards (identified as needed, under development, or available).
In October 2023, FDA published “Guidance for Industry: Voluntary Consensus Standards Recognitions Program for Regenerative Medicine Therapies”. This guidance describes a standards recognition program (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards 1 (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. CBER encourages the use of appropriate standards in the development of CBER-regulated products. The use of recognized VCS can assist stakeholders in meeting regulatory requirements more efficiently and increasing regulatory predictability for RMT products. CBER is posting a list of recognized standards on this page as stated in the guidance.
CBER Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
Last updated on November 28, 2023
| Recognition Number | SDO | Designation ID | Year | Title | Recognition Status | Standard Recognition Summary (SRS) |
|---|---|---|---|---|---|---|
| 001 | ASTM | F2944 | 2020 | Standard Practice for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture | Complete Recognition | Rec 001 |
| 002 | ANSI/ PDA |
02 | 2021 | Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing: An Introduction and Best Practices Approach on How to Prepare, Cryopreserve, and Recover Cells, Cell Lines, and Cell-Based Tissue Products | Complete Recognition | Rec 002 |
| 003 | ASTM | F2212 | 2020 | Standard Guide for Characterization of Type 1 Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) | Complete Recognition | Rec 003 |
| 004 | ASTM | F2739 | 2019 | Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds | Partial Recognition | Rec 004 |
| 005 | ASTM | F3206 | 2017 | Standard guide for assessing medical device cytocompatibility | Complete Recognition | Rec 005 |
| 006 | ISO | 20395 | 2019 | Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - qPCR and dPCR | Complete Recognition | Rec 006 |
| 007 | ISO | 20397-2 | 2020 | Massively parallel sequencing — Part 2: Quality evaluation of sequencing data | Complete Recognition | Rec 007 |
| 008 | ISO | 20397-1 | 2022 | Massively parallel sequencing — Part 1: Nucleic acid and library preparation | Complete Recognition | Rec 008 |
| 009 | ISO | 20688-1 | 2020 | Biotechnology — Nucleic acid synthesis — Part 1: Requirements for the production and quality control of synthesized oligonucleotides | Complete Recognition | Rec 009 |
| 010 | ISO | 21560 | 2020 | General requirements of tissue-engineered medical products | Complete Recognition | Rec 010 |
| 011 | ISO | 23033 | 2021 | General requirements and considerations for the testing and characterization of cellular therapeutic products | Complete Recognition | Rec 011 |
| 019 | ISO | 21973 | 2020 | General requirements for transportation of cells for therapeutic use | Complete Recognition | Rec 019 |
| 021 | ASTM | F3259 | 2017 | Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds | Complete Recognition | Rec 021 |
| 023 | ASTM | F3106 | 2022 | Standard guide for in vitro Osteoblast Differentiation Assays | Complete Recognition | Rec 023 |
| 025 | ISO | 20399 | 2022 | Biotechnology - Ancillary materials present during the production of cellular therapeutic products and gene therapy products | Complete Recognition | Rec 025 |
- 1OMB Circular A -119: Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities, January 2016.