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 (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 December 13, 2024
| Posting Date | SDO | Designation ID | Publication Year | Title | Recognition Status | Standard Recognition Summary (SRS) |
|---|---|---|---|---|---|---|
| 12/12/2023 | 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 | SRS ASTM F2944 |
| 12/12/2023 | 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 | SRS ANSI PDA02 |
| 12/12/2023 | 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 | SRS ASTM F2212 |
| 12/12/2023 | ASTM | F2739 | 2019 | Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds | Partial Recognition | SRS ASTM F2739 |
| 12/08/2025 | ASTM | F3206 | 2025 | Standard guide for assessing medical device cytocompatibility | Complete Recognition | SRS ASTM F3206 |
| 12/12/2023 | ISO | 20395 | 2019 | Biotechnology – Requirements for evaluating the performance of quantification methods for nucleic acid target sequences – qPCR and dPCR | Complete Recognition | SRS ISO 20395 |
| 12/12/2023 | ISO | 20397-2 | 2020 | Massively parallel sequencing — Part 2: Quality evaluation of sequencing data | Complete Recognition | SRS ISO 20397-2 |
| 12/12/2023 | ISO | 20397-1 | 2022 | Massively parallel sequencing — Part 1: Nucleic acid and library preparation | Complete Recognition | SRS ISO 20397-1 |
| 12/12/2023 | ISO | 20688-1 | 2020 | Biotechnology — Nucleic acid synthesis — Part 1: Requirements for the production and quality control of synthesized oligonucleotides | Complete Recognition | SRS ISO 20688-1 |
| 12/12/2023 | ISO | 21560 | 2020 | General requirements of tissue-engineered medical products | Complete Recognition | SRS ISO 21560 |
| 12/12/2023 | ISO | 23033 | 2021 | General requirements and considerations for the testing and characterization of cellular therapeutic products | Complete Recognition | SRS ISO 23033 |
| 12/12/2023 | ISO | 21973 | 2020 | General requirements for transportation of cells for therapeutic use | Complete Recognition | SRS ISO 21973 |
| 12/12/2023 | ASTM | F3259 | 2017 | Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds | Complete Recognition | SRS ASTM F3259 |
| 12/12/2023 | ASTM | F3106 | 2022 | Standard guide for in vitro Osteoblast Differentiation Assays | Complete Recognition | SRS ASTM F3106 |
| 12/12/2023 | ISO | 20399 | 2022 | Biotechnology – Ancillary materials present during the production of cellular therapeutic products and gene therapy products | Complete Recognition | SRS ISO 20399 |
| 06/14/2024 | ASTM | F2997 | 2021 | Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis | Complete Recognition | SRS ASTM F2997 |
| 06/14/2024 | ISO | 10993-1 | 2018 | Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process | Partial Recognition | SRS ISO 10993-1 |
| 06/14/2024 | ASTM | F3504 | 2021 | Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method | Complete Recognition | SRS ASTM 3504 |
| 06/14/2024 | ISO | 13019 | 2018 | Tissue-engineered medical products – Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis | Complete Recognition | SRS ISO 13019 |
| 12/10/2024 | ISO | 20391-2 | 2018 | Biotechnology – Cell counting – Part 2: Experimental design and statistical analysis to quantify counting method performance | Complete Recognition | SRS ISO 20391-2 |
| 12/10/2024 | ISO | 24420 | 2023 | Biotechnology – Massively parallel DNA sequencing – General requirements for data processing of shotgun metagenomic sequences | Complete Recognition | SRS ISO 24420 |
| 12/10/2024 | ISO | 23511 | 2023 | Biotechnology — General requirements and considerations for cell line authentication | Complete Recognition | SRS ISO 23511 |
| 12/15/2025 | ASTM | F2027 | 2025 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products | Complete Recognition | SRS ASTM F2027 |
| 12/10/2024 | ASTM | F2150 | 2019 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products | Complete Recognition | SRS ASTM F2150 |
| 12/10/2024 | ISO | 20391-1 | 2018 | Biotechnology — Cell counting — Part 1: General guidance on cell counting methods | Complete Recognition | SRS ISO 20391-1 |
| 12/09/2025 | ISO | 10993-5 | 2009 | Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | Complete Recognition | |
| 12/09/2025 | ISO | 22442-1 | 2020 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management | Partial Recognition | SRS ISO 22442-1 |
| 12/09/2025 | ISO | 22442-2 | 2020 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling | Complete Recognition | SRS ISO 22442-2 |
| 12/09/2025 | ISO | 22442-3 | 2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of elimination/inactivation of viruses and TSE agents | Complete Recognition | SRS ISO 22442-3 |
| 12/09/2025 | ASTM | F2132 | 2021 | Standard Test Method for In Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line | Complete Recognition | SRS ISO F2132 |
| 12/09/2025 | ISO | 24421 | 2023 | Biotechnology — Minimum requirements for optical signal measurements in photometric methods for biological samples | Complete Recognition | SRS ISO 24421 |
| 12/09/2025 | ASTM | F3659 | 2024 | Standard Guide for Bioinks Used in Bioprinting | Complete Recognition | SRS ASTM F3659 |
| 12/09/2025 | ISO | 8392 | 2023 | Genomics informatics — Description rules for genomic data for genetic detection products and services | Complete Recognition | SRS ISO 8392 |
| 12/09/2025 | ASTM | F2315 | 2018 | Standard guide for immobilization or encapsulation of living cells or tissue in alginate gels | Complete Recognition | SRS ASTM F2315 |
| 12/09/2025 | ASTM | F3294 | 2024 | Standard Guide for Performing Quantitative Fluorescence Intensity Measurements in Cell-based Assays with Wide-Field Epifluorescence Microscopy | Complete Recognition | SRS ASTM F3294 |
| 12/09/2025 | ASTM | F2064 | 2025 | Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Applications | Complete Recognition | SRS ASTM F2064 |
| 12/09/2025 | ASTM | F3716 | 2025 | Standard Test Method for Cumulative Population Doubling Analysis of the Proliferation of Vertebrate Tissue Cell Preparations | Complete Recognition | SRS ASTM F3716 |
| 12/09/2025 | ASTM | F2131 | 2021 | Standard Test Method for In Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line (variant designation) | Complete Recognition | SRS ASTM F2131 |
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Content current as of:
12/19/2025
