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FDA Updates Recognized Consensus Standards List, Covering Dental, Cardiovascular, Orthopedic and Other Sectors

Time：2026-08-28 11:08:44

On August 24, 2026, the U.S. Food and Drug Administration (FDA) officially issued Recognition List Number: 066, which rolled out a new‑round revision to the Recognized Voluntary Consensus Standards List for medical device pre‑market review. This update spans multiple sectors including biocompatibility, cardiovascular, dental, orthopedic, and medical software. It covers new standard additions, version replacements, withdrawals, and transition‑period adjustments. All revisions took effect on the date of publicationFederal Re...

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https://www.federalregister.gov/documents/2026/08/24/2026-17229/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized

一、Core Document Information

This regular list maintenance is implemented under the Food and Drug Administration Modernization Act of 1997 (FDAMA), marking the 66th formal revision of the Recognized Consensus Standards List.

Issuing Body: U.S. FDA Center for Devices and Radiological Health (CDRH)
Effective Date: August 24, 2026
Scope of Changes: Addition of new standards, withdrawal & replacement of old standards, data correction, adjustment of recognition scope, transition‑period extension
Docket Number: FDA‑2004‑N‑0451

二、Four Types of Regulatory Revisions

Withdrawal of old standards and replacement with newer editions：This represents the predominant change. Once international or national standard‑setting organizations release updated versions, FDA withdraws recognition for superseded editions and adopts the latest versions. New submissions from manufacturers shall apply updated standards accordingly.

Adoption of newly‑recognized standards：Previously‑unrecognized industry standards are formally added to the list. Manufacturers may reference these newly‑included standards for Declaration of Conformity in pre‑market submissions, opening new streamlined compliance pathways.

Correction of standard records：Fixing administrative entry errors or adjusting the official scope of recognition for existing standards.

Extension of transition periods：Extended buffer windows for certain standards undergoing version migration, allowing continued use of older editions for ongoing submissions within the transition timeframe.

三、Key Sector‑by‑Sector Changes

（一）Biocompatibility

Biocompatibility standards are essential for nearly all medical devices. Two core ISO standards have been updated in this round:

ISO 10993‑1:2025 (6th Edition): General requirements for biological evaluation of medical devices, updating principles for biosafety assessment under risk‑management frameworks.
ISO 10993‑12:2021 + AMD1:2025: Revised requirements for sample preparation and reference materials for biological testing.

Compliance Note: Sponsors for new pre‑market submissions are recommended to migrate to the 2025 revisions. Confirm test laboratories hold valid accreditation for these updated standards.

（二）Dental

Dental devices see the largest volume of new entries in this release, with 31 newly‑recognized standards, combining ANSI/ADA national standards and ISO international standards.

ANSI/ADA series (7 standards): Periodontal curettes, dental tweezers, denture adhesives, casting investments, periodontal probes and others.
ISO dental series (24 standards): Dental explorers (ISO 7492), dental extraction forceps (ISO 9173‑1/2/3), magnetic attachments (ISO 13017), dental furnace test suites (ISO 13078 series), periodontal curettes & scalers (ISO 13397 series), duplicating materials (ISO 14356), orthodontic coiled springs (ISO 17254), minimum dataset for dental implants (ISO 16498), stainless‑steel specifications for dental instruments (ISO 21850‑1), CAD/CAM milling accuracy testing (ISO 23298), etc.

For numerous dental medical devices, sponsors may now satisfy FDA requirements by submitting Declarations of Conformity against these standards, which substantially reduces required verification test data and cuts time‑to‑market and laboratory‑testing costs.

（三）Cardiovascular

Full‑set updates for ISO 5840 series standards covering cardiac valve prostheses, with all three parts incorporating 2025 amendments:

ISO 5840‑1: General requirements for cardiac valve prostheses
ISO 5840‑2: Surgically‑implanted heart valve substitutes
ISO 5840‑3: Transcatheter‑implanted heart valve substitutes

In addition, ASTM F2942‑25, the standard for in‑vitro durability testing of vascular stents and stent‑grafts, has superseded its prior edition.

（四）Orthopedics

Eight standards have been updated with newer editions, and two obsolete standards are formally withdrawn. Revisions focus on mechanical‑performance and wear‑test protocols for orthopedic implants:

ASTM F2789‑25: Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
ISO 7206‑12:2025: Deformation test method for press‑fit acetabular hip‑prosthesis components
ASTM F2706‑25: Test methods for occipital‑cervical and occipital‑cervical‑thoracic spinal‑implant constructs
ISO 18192‑3:2025: Impingement‑wear testing for total intervertebral spinal‑disc prostheses (lumbar & cervical)
ASTM F3574‑25: Standard Test Methods for Sacroiliac Joint Fusion Devices, and more.

（五）Medical Software & Cybersecurity

CVSS 3.1 (Common Vulnerability Scoring System version 3.1): Transition period extended. Manufacturers may keep using this framework for cybersecurity risk assessment of medical devices.
IEEE 11073‑10207:2017 + Cor 1‑2025: Updated point‑of‑care medical‑device communication standard including the 2025 corrigendum.
Newly‑adopted IEEE 1752.1‑2021: Open Mobile Health Data standard covering metadata, sleep‑tracking and physical‑activity metrics, supporting regulatory submissions for consumer‑oriented digital‑health devices.

（六）Other Notable Revisions

Anesthesiology: ISO 10079‑1 (Fourth edition 2022‑03 + AMD1:2026) for electrically‑powered medical suction equipment replaces the former version.
Hemodialysis: All five parts of ISO 23500 (preparation and quality management of fluids for hemodialysis and related therapies) upgraded to the second edition.
Radiology: IEC 63465:2026‑01 for radionuclide calibrator calibration and QC newly recognized, superseding two older standards.
Rehabilitation & Wheelchairs: Updated EMC standard for power‑driven wheelchairs; new standard for lithium‑ion battery systems of powered wheelchairs is added.

四、Compliance Recommendations for Medical Device Manufacturers

Immediate version gap‑check：Review standards referenced for devices under R&D or undergoing pre‑market review. Identify standards that are withdrawn or superseded per Recognition List 066. Legacy editions are no longer officially recognized as of August 24 2026. New submissions are strongly advised to reference current updated standards.

Evaluate technical differences and schedule document updates：For products affected by standard revisions, compare technical requirements between old and new editions. Assess whether supplementary testing, risk‑management‑file revisions or technical‑file updates are necessary. Prioritize version migration for imminently‑due submissions to avoid project delays.

Leverage newly‑adopted standards to optimize submission strategies：For dental, mobile‑health and other product categories covered by newly‑added standards, integrate these consensus standards into development and verification workflows. Declarations of conformity can streamline FDA submission pathways, lowering overall costs and shortening market‑access timelines.

Establish ongoing standards‑tracking workflows：FDA revises its Recognized Consensus Standards List on an as‑needed basis. Companies should embed standards monitoring into routine compliance operations to mitigate risks of using obsolete standards at late submission stages.

五、Closing Remarks

For manufacturers pursuing FDA 510(k) clearance or De Novo classification for U.S. market access, referencing FDA‑recognized consensus standards via Declaration of Conformity is a key strategy to streamline regulatory review, reduce experimental‑data burdens and accelerate authorization. This round of standard‑version migration will directly impact technical documentation and test requirements for a wide range of medical‑device products. Relevant enterprises are advised to conduct self‑audits promptly.Should you require further consultation on regulatory compliance, please reach out to Wiselink.

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