Key changes to the final guidance and test methods include:
“Porous materials” was updated to “soft surface textiles” throughout the guidance and test methods, which is defined as: soft, porous or non-porous surface that includes the outer surface of non-clothing fabrics/textiles in clinical and institutional (non-residential) environments where spot treatment is the primary means of disinfection.
The specific color requirement of the fabric to be used in testing was removed but the specific fabric vendor and the three fabric types remain the same.
The use of 1 cm2 fabric carriers have been added in addition to the original 1 cm diameter pieces of each of the three different fabric types.
The EPA clarified that the cytotoxicity control for viral testing and the neutralization assay for all microorganisms can be performed prior to or concurrently with testing. If performed prior to testing, it is not required to also be conducted during efficacy testing.
A new test interference control was added to the neutralization assay. This control is to determine if the fabric carrier interferes with the test system (microorganism and test substance).
The wetness test requirement listed in the draft guidance has been removed.
The compatibility of the product with the porous material per the proposed label requirement from the draft guidance has been removed.