April 30, 1998 - FDA Microbial Reagent Exemption

Dockets Management Branch
(HFA-305)
Food and Drug Administration
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Department of Health and Human Services, Food and Drug Administration, Medical Devices; Exemptions From Premarket Notification; Class II Devices, Docket No. 98N-0015, January 21, 1998

The American Society for Microbiology appreciates the opportunity to submit comments on the Food and Drug Administration (FDA) regulatory Notice published in the Federal Register on January 21, 1998. The ASM is the largest single life science membership organization in the world, representing over 43,000 scientists who work in clinical, public health, research and industrial laboratories. ASM members use the reagents and devices listed in the FDA's Notice on a daily basis and rely on the product's safety and effectiveness to detect and diagnose infectious diseases.

The ASM recommends the FDA remove nine (9) Class II devices from the list of exempted devices. After careful consideration and review, the ASM believes if the FDA exempts the following nine devices it will poses a serious public health hazard and therefore, these serological reagents should not be exempt from Class II review. The following serological reagents fail to meet the criteria for declassification as described in the regulatory notice as 'Limitations on Exemptions'. The following reagents are used to or assist in "screening, diagnosis, or monitoring life threatening diseases". The serological reagents are used to detect and diagnose high risk, sometimes fatal, infectious diseases for which general controls for the device are not possible. Device failure will not be "readily detectable by users by visual examination or other means such as routine testing before causing harm" as stated in the FDA Notice.

866.3060 Blastomyces dermatitidis serological reagents:
866.3085 Brucella spp. serological reagents:
866.3135 Coociodides immitis serological reagents:
866.3320 Histoplasma capsulatum serological reagents:


The above serological reagents are all used to diagnose systemic fungi which causes serious infection in patients. The laboratory professional relies on these reagents to diagnose serious fungal infections which require appropriate anti-fungal therapy. Mis-diagnosis could seriously impact patient health and could cause inappropriate treatment, including unnecessary anti-microbial therapy. In the case of Brucella, failure to accurately diagnose this organism could hamper a public health investigation into a common source outbreak of foodborne disease.

866.3165 Cryptococcus neoformans serological reagents:

This organism causes infections in the immunocomprised (including individuals with acquired human immunodeficiency virus) and can cause meningitis. These types of patients and life threatening situations leave no opportunity to make a wrong decision which could delay treatment or cause inappropriate therapy.

866.3220 Entamoeba histolytica serological reagents:

This organism is responsible for infections in both immunocompetent and immunocomprimised patients and can cause amebic dysentery and potential liver abscess. The laboratory professional relies on these reagents to diagnose potentially serious infection which requires appropriate therapy. Misdiagnosis could lead to serious sequelae for the patient. Results of these procedures are used to differentiate an infectious parasitic process (amebiasis), rather than a tumor or possible bacterial abscess; treatment for these three are quite different.

866.3280 Franciscella tularensis serological reagents:

This organism is difficult to cultivate and is considered a "select infectious agent" by the Centers for Disease Control and Prevention. This serological reagent has to work consistently. Exempting this reagent from a Class II review is risky and could cause potential harm to the laboratory worker. This organism can cause life threatening disease with serious public health consequences.

866.3350 Leptospira spp. serological reagents:

This organism causes serious bacterial disease of the liver and is considered a systemic disease. Class II review is warranted.

866.3460 Rabiesvirus immunofluorescent reagents:

These reagents are critical in both patient care and public health surveillance. Accurate, safe and effective reagents are crucial in the diagnosis of rabies. Inadequate antibody activity could result in death of an individual bitten by a rabid animal and misdiagnosis of rabies could trigger painful and unnecessary vaccination of patients (many of whom are children). Laboratory professionals depend on these reagents to work each and every time and expect the reagents to have gone through appropriate FDA Class II device review.

The ASM understands the FDA's need to respond to the Food and Drug Administration Modernization Act of 1997 and supports the agency's goal to eliminate unnecessary regulatory requirements. However, the ASM urges the FDA to remove the above nine serological reagents from the list of exempted Class II devices to protect the public health as well as ensure the safety of the laboratory professional. The ASM also recommends the FDA seek to communicate the impending changes at FDA with the clinical microbiology community. The ASM concurs with the FDA decision to withhold exemption from antigen detection systems. Thank you for the opportunity to submit comments on this important issue. The ASM would be pleased to work with the FDA as the agency continues to implement the Food and Drug Administration Modernization Act of 1997.

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