The U.S. Food and Drug Administration (FDA) CDRH announced today that it has published a new batch of recognized standards effective May 25, 2026, covering a broad range of medical device categories. The update includes both complete and partial recognitions, spanning ISO, IEC, ASTM, ANSI/ADA, IEEE, and FIRST standards bodies.
A total of 45 standard references were added to the FDA database in this release. Dental and ENT devices account for the largest share, with 32 entries covering instrumentation, materials, and implants. The remaining entries are distributed across cardiovascular, orthopedic, biocompatibility, and several other specialty areas.
Dental / ENT
32
new entries
Orthopedic
6
new entries
Cardiovascular
4
new entries
Other areas
13
new entries
across 10 specialties
Notable inclusions span a wide spectrum of disciplines. In the cardiovascular space, three standards addressing cardiac valve prostheses (ISO 5840 series) received recognition, including amendments adopted in 2025. For orthopedic implants, updated ASTM and ISO test method standards were added, covering hip prostheses, spinal disc prostheses, and sacroiliac joint fusion devices.
The biocompatibility category saw updates to ISO 10993-1 (sixth edition, 2025) and ISO 10993-12, both relevant to biological evaluation of medical devices. In the software and informatics area, CVSS v4.0 for cybersecurity vulnerability scoring and two IEEE health informatics standards were recognized. The materials category gained three ASTM entries, including a revised standard for MR environment marking (F2503-26).
Several standards received partial recognition, meaning only specific sections are covered under the FDA framework. These include ISO 10993-1 (biocompatibility), ISO 5840-1 (cardiovascular), ISO 23500-1 and 23500-4 (haemodialysis fluids), and IEC 80601-2-26 (electroencephalographs).
Why ISO 10993-1 received only partial recognition
The sixth edition of ISO 10993-1 (2025) was not granted full recognition by the FDA for two specific reasons. First, the phrase “consumer products” in clause 6.5.11.3 conflicts with existing FDA guidance on biocompatibility, which does not accept all consumer product materials as automatically suitable reference points for medical device evaluation. Second, clause 6.9 on biological risk estimation conflicts with ISO 14971:2019, the FDA-recognized standard for risk management, whose own risk estimation framework takes precedence.
Manufacturers should also be aware that the additional genotoxicity evaluation requirements introduced in Tables 2, 3, 4 and clause 6.5.7 of the new edition may not fully align with FDA’s existing guidance for all prolonged contact devices. The FDA recommends contacting the relevant review office before beginning biological evaluation based on these specific clauses.
The previous fifth edition (2018) remains accepted until July 1, 2029, after which only the sixth edition will be recognized.
FDA recognition of a standard does not constitute a requirement to use it, but enables manufacturers to reference it in 510(k) and other premarket submissions as evidence of conformance to applicable performance criteria.
The full updated list is available through the FDA recognized standards database. Manufacturers and regulatory affairs teams are advised to verify the specific edition and scope of each recognition before citing standards in submissions.