1. (a) Identification. A foam or gel chemical sterilant/high level disinfectant is a germicide in the form of a foam or gel that is intended for use as the terminal step in high level disinfection of medical devices prior to patient use.

2. (b) Classification. Class II (special controls). The special controls for this device are:

   1. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated under challenging conditions:

      1. (i) Storage stability testing must demonstrate the real time stability and dynamics of the device formulation within the expiration date (shelf life) of the unopened product and within a use period of the opened container from the date of opening under the proposed storage conditions;
      2. (ii) Transport stability testing must demonstrate device resilience to transport conditions (such as temperature, pressure, and humidity), environmental factors (such as freeze and thaw), and mechanical impacts (such as the effect of drops on package integrity);
      3. (iii) Potency testing must demonstrate the sporicidal, mycobactericidal, fungicidal, bactericidal, and virucidal activities of the device;
      4. (iv) Simulated use testing must use the mycobacterium species most resistant to the germicide as the test organism on inoculated instruments to demonstrate a kill of at least 10 ⁶ inoculated mycobacteria under the labeled contact time;
      5. (v) In-use testing must test clinically-relevant microorganism on clinically used instruments, in accordance with the labeled contact conditions for high level disinfection, to confirm the results of simulated use testing;
      6. (vi) Testing must demonstrate compatibility with labeled devices and materials; and
      7. (vii) Chemical indicator validation must demonstrate a characteristic chemical reaction to the concentration of active ingredients of the germicide.
   2. (2) The device must be demonstrated to be biocompatible.
   3. (3) Human factors testing must demonstrate that the device can be used correctly, based solely on the device labeling.

   4. (4) Labeling must include:

      1. (i) Directions for use, including:

         1. (A) Instructions for preparation and use of the germicide; cleaning steps in preparation for high level disinfection; high level disinfections of cleaned devices; rinsing, neutralizing, and removing residues, when needed; and reuse of the solution, if applicable; and
         2. (B) Chemical indicator for monitoring the minimum effective concentration or minimum recommended concentration of the product's active ingredient(s);
      2. (ii) Instructions for personal protective equipment to be used with the device;
      3. (iii) Instructions for disposal of the germicide and any neutralizers, including an instruction to check local and state regulations;
      4. (iv) Storage conditions and expiration date information for stock solution, opened containers, activated solution, and use-dilution;
      5. (v) A statement that the end user should be trained in the reprocessing (decontamination and sterilization or disinfection) of medical devices and in the handling of toxic substances, such as liquid chemical germicides;
      6. (vi) The germicide classification scheme;
      7. (vii) General information on selection and use of germicides for medical device reprocessing;
      8. (viii) Material and device compatibility and incompatibility information;
      9. (ix) The microbial mode of action of germicidal activity;
      10. (x) Precleaning agent/method compatibility and incompatibility; and
      11. (xi) The toxicology profile of the final product formulation and information on adverse reactions following exposure to the product.

[91 FR 38505, June 26, 2026]