FDA GMP Medical Device Disinfectant AOAC Testing

Laboratory Test Request Description

FDA GMP Medical Device Microbiology Laboratory needed for AOAC testing of 2 Medical Device Disinfectants. One with Benzalkonium Chloride (BKC) and one with Didecyl Dimethyl Ammonium Chloride DDAC. that are diluted 1:100 before use. We are usually sending each batch for log reduction bacteriological activity study in India. Our both the product exposure time is 15 min. We are planning to register our product at US FDA, under Class : Class I Disinfectant for Non Critical Medical Device.
For the same, we need to test our product as per AOAC standards, which are mentioned below.
 AOAC 6.2.02:2006 (Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method)
 AOAC 6.2.03:2006 (Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method)
 AOAC 6.2.05:2006 (Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method)
 AOAC 6.3.02:2006 (Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes)
 AOAC 6.2.04:2013 (Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus, Use-Dilution Method)
 AOAC 6.3.05:2013 (Official Method 966.04, Sporicidal Activity of Disinfectants Method I)
 AOAC 6.3.06:2012 (Official Method 965.12 Tuberculocidal Activity of Disinfectants)
 AOAC 6.2.01:2013 (Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method)
 AOAC 6.2.06:2013 (Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method)
 ANSI AAMI ST58:2013/(R)2018 (Chemical sterilization and high-level disinfection in health care facilities)

Kindly provide me relevant detail including the test cost, quantity of sample required to perform all above mentioned test etc.

Also wanted to know that Disinfectant for Non Critical Medical Device use only, need to registered with EPA also or not required to register with EPA for medical device use only.


Number: 22-01279

Industry: Medical Devices

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