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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 December 13, 2024

 

Posting DateSDODesignation IDPublication YearTitleRecognition StatusStandard Recognition Summary (SRS)
12/12/2023ASTMF29442020Standard Practice for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in CultureComplete RecognitionSRS ASTM F2944
12/12/2023ANSI/
PDA		022021Cryopreservation 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 ProductsComplete RecognitionSRS ANSI PDA02
12/12/2023ASTMF22122020Standard Guide for Characterization of Type 1 Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)Complete RecognitionSRS ASTM F2212
12/12/2023ASTMF27392019Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial ScaffoldsPartial RecognitionSRS ASTM F2739
12/12/2023ASTMF32062017Standard guide for assessing medical device cytocompatibilityComplete RecognitionSRS ASTM F3206
12/12/2023ISO203952019Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - qPCR and dPCRComplete RecognitionSRS ISO 20395
12/12/2023ISO20397-22020Massively parallel sequencing — Part 2: Quality evaluation of sequencing dataComplete RecognitionSRS ISO 20397-2
12/12/2023ISO20397-12022Massively parallel sequencing — Part 1: Nucleic acid and library preparationComplete RecognitionSRS ISO 20397-1
12/12/2023ISO20688-12020Biotechnology — Nucleic acid synthesis — Part 1: Requirements for the production and quality control of synthesized oligonucleotidesComplete RecognitionSRS ISO 20688-1
12/12/2023ISO215602020General requirements of tissue-engineered medical productsComplete RecognitionSRS ISO 21560
12/12/2023ISO230332021General requirements and considerations for the testing and characterization of cellular therapeutic productsComplete RecognitionSRS ISO 23033
12/12/2023ISO219732020General requirements for transportation of cells for therapeutic useComplete RecognitionSRS ISO 21973
12/12/2023ASTMF32592017Standard Guide for Micro-computed Tomography of Tissue Engineered ScaffoldsComplete RecognitionSRS ASTM F3259
12/12/2023ASTMF31062022Standard guide for in vitro Osteoblast Differentiation AssaysComplete RecognitionSRS ASTM F3106
12/12/2023ISO203992022Biotechnology - Ancillary materials present during the production of cellular therapeutic products and gene therapy productsComplete RecognitionSRS ISO 20399
06/14/2024ASTMF29972021Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image AnalysisComplete RecognitionSRS ASTM F2997
06/14/2024ISO10993-12018Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management processPartial RecognitionSRS ISO 10993-1
06/14/2024ASTMF35042021Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive MethodComplete RecognitionSRS ASTM 3504
06/14/2024ISO130192018Tissue-engineered medical products - Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesisComplete RecognitionSRS ISO 13019
12/10/2024ISO20391-22018Biotechnology - Cell counting - Part 2: Experimental design and statistical analysis to quantify counting method performanceComplete RecognitionSRS ISO 20391-2
12/10/2024ISO244202023Biotechnology - Massively parallel DNA sequencing - General requirements for data processing of shotgun metagenomic sequencesComplete RecognitionSRS ISO 24420
12/10/2024ISO235112023Biotechnology — General requirements and considerations for cell line authenticationComplete RecognitionSRS ISO 23511
12/10/2024ASTMF20272016Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical ProductsComplete RecognitionSRS ASTM F2027
12/10/2024ASTMF21502019Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical ProductsComplete RecognitionSRS ASTM F2150
12/10/2024ISO20391-12018Biotechnology — Cell counting — Part 1: General guidance on cell counting methodsComplete RecognitionSRS ISO 20391-1
  • 1<a href="https://obamawhitehouse.archives.gov/sites/default/files/omb/inforeg/revised_circular_a-119_as_of_1_22.pdf">OMB Circular A -119: Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities, January 2016</a>.
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