# 2026-12899: FDA Simplifies Rules for Foam Chemical Sterilants

2026-12899, Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-06-26, effective 2026-06-26; PRIA reads it as touching household money (as of 2026-07-03).

- Canonical: https://policyrisk.com/federal-register/2026-12899
- As of: 2026-07-03
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-12899
- Title: Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 38504
- Published: 2026-06-26
- Effective: 2026-06-26
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-07-03

## In one line

FDA Simplifies Rules for Foam Chemical Sterilants

## Summary

The FDA is officially putting foam or gel chemical sterilants and high-level disinfectants into Class II, meaning they’ll have special safety rules but fewer red tape hurdles. This change helps companies bring safer, innovative cleaning products to hospitals and homes faster, starting June 26, 2026. If you make or use these devices, expect smoother approvals and better access without extra costs or delays.

## Abstract

The Food and Drug Administration (FDA) is classifying the foam or gel chemical sterilant/high level disinfectant into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the foam or gel chemical sterilant/high level disinfectant. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

## Effects PRIA read

- Reclassified to Class II; Codified Rule: benefit, medium. The FDA formally classified foam or gel chemical sterilants/high level disinfectants as Class II (special controls) and added the device type to 21 CFR 880.6886. This order is effective June 26, 2026 (classification applicable June 2, 2023), and lets these devices serve as predicates so future devi…
- Faster Access to Safer Disinfectants: benefit, low. Because FDA placed foam or gel chemical sterilants/high level disinfectants into Class II, patients and households may get safer, innovative cleaning products in hospitals and homes more quickly starting June 26, 2026. FDA says this classification will enhance patients' access by reducing regulator…
- New Testing and Labeling Requirements: cost, medium. Manufacturers must meet specific special controls and remain subject to premarket notification (510(k)). Required controls include non-clinical performance testing (storage and transport stability, potency, simulated use and in-use testing), demonstrating at least a 1,000,000 (10^6) kill of the mos…

## Related documents

- [2026-20848](https://policyrisk.com/federal-register/2026-20848): Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods, 2026-10-13
- [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11
- [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13
- [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29
- [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25
- [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27

## Sources
- [2026-12899 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/26/2026-12899/medical-devices-general-hospital-and-personal-use-devices-classification-of-the-foam-or-gel-chemical)
- [2026-12899 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12899.pdf)

## Related
- [Previous: 2026-12898, Air Plan Approval; District of Columbia; Creation of Synthetic Minor Permit Pro…](https://policyrisk.com/federal-register/2026-12898)
- [Next: 2026-12900, Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of t…](https://policyrisk.com/federal-register/2026-12900)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-12899 (as of 2026-07-03).