Dear all, please see the latest updates to the FDA Consensus standards.
| Date of Entry | Specialty Task Group Area | Recognition Number | Extent of Recognition | Standard Developing Organization | Standard Designation Number/Date | Title of Standard | Transition Expiration Date |
| 12/22/2025 | Biocompatibility | 2-308 | Complete | ASTM | F1984-25 | Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials | |
| 12/22/2025 | Biocompatibility | 2-309 | Complete | ASTM | F895-25 | Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity | |
| 12/22/2025 | Biocompatibility | 2-310 | Complete | ASTM | F748-25 | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices | |
| 12/22/2025 | Biocompatibility | 2-311 | Complete | ISO | 10993-4 Third edition 2017-04 [Including AMD1:2025] | Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)] | |
| 12/22/2025 | Biocompatibility | 2-312 | Complete | ASTM | F720-24 | Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test | |
| 12/22/2025 | General I (QS/RM) | 5-146 | Complete | ISO | 80369-6 Second edition 2025-05 | Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications | |
| 12/22/2025 | General I (QS/RM) | 5-147 | Complete | ISO | 80369-1 Third edition 2025-10 | Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements | |
| 12/22/2025 | General I (QS/RM) | 5-148 | Complete | ISO | 15223-1 Fourth edition 2021-07 [Including AMD1: 2025] | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements [Including Amendment 1 (2025)] | |
| 12/22/2025 | InVitro Diagnostics | 7-346 | Complete | CLSI | EP32 2nd Edition | Implementation of Metrological Traceability in Laboratory Medicine | |
| 12/22/2025 | InVitro Diagnostics | 7-347 | Complete | CLSI | EP21 3rd Edition | Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures | |
| 12/22/2025 | InVitro Diagnostics | 7-348 | Complete | CLSI | EP37 2nd Edition | Supplemental Tables for Interference Testing in Clinical Chemistry | |
| 12/22/2025 | InVitro Diagnostics | 7-349 | Complete | CLSI | EP35 2nd Edition | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures | |
| 12/22/2025 | InVitro Diagnostics | 7-351 | Complete | CLSI | EP46 1st Edition | Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures | |
| 12/22/2025 | Software/Informatics | 13-150 | Complete | IEEE | Std 11073-10472-2023 | Health informatics – Device Interoperability – Part 10472: Personal Health Device Communication – Device Specialization – Medication Monitor | |
| 12/22/2025 | Software/Informatics | 13-150 | Complete | ISO IEEE | 11073-10472 Second edition 2024-09 | Health informatics – Device Interoperability – Part 10472: Personal health device communication – Device specialization – Medication monitor | |
| 12/22/2025 | Software/Informatics | 13-151 | Complete | IEEE | Std 11073-10421-2023 | Health Informatics-Device Interoperability – Part 10421: Personal Health Device Communication – Device Specialization – Peak expiratory flow monitor (peak flow) | |
| 12/22/2025 | Software/Informatics | 13-151 | Complete | ISO IEEE | 11073-10421 Second Edition 2024-08 | Health informatics – Device Interoperability – Part 10421: Personal health device communication – Device specialization – Peak expiratory flow monitor (peak flow) | |
| 12/22/2025 | Software/Informatics | 13-152 | Complete | ISO | TS 5615:2025 | Health informatics – Accelerating safe effective and secure remote connected care and mobile health through standards-based interoperability solutions addressing gaps revealed by pandemics | |
| 12/22/2025 | Software/Informatics | 13-153 | Complete | AAMI | CR515:2025 | Cybersecurity Consideration Unique to Machine-Learning Enabled Medical Devices | |
| 12/22/2025 | Software/Informatics | 13-154 | Complete | IEEE | Std 11073-10429-2022 | Health informatics – Device Interoperability – Part 10429: Personal Health Device Communication – Device Specialization – Spirometry | |
| 12/22/2025 | Software/Informatics | 13-155 | Complete | IEEE | Std 11073-10442-2023 | Health informatics – Device Interoperability Part 10442: Personal health device communication – Device specialization – Strength fitness equipment | |
| 12/22/2025 | Software/Informatics | 13-156 | Complete | IEEE | Std 11073-10471-2023 | Health Informatics – Device interoperability – Part 10471: Personal health device communication – Device specialization – Independent living activity hub | |
| 12/22/2025 | Software/Informatics | 13-156 | Complete | ISO IEEE | 11073-10471 Second Edition 2024-09 | Health Informatics – Device Interoperability – Part 10471: Personal Health Device Communication – Device Specialization-Independent Living Activity Hub | |
| 12/22/2025 | Sterility | 14-612 | Complete | USP-NF | M16015_02_01 | <86> Bacterial Endotoxins Test Using Recombinant Reagents |
