May 7, 1998 - FDA Microbial Reagent and Medical Devices Exemptions

Dockets Management Branch
(HFA-305)
Food and Drug Administration
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Rockville, MD 20857

Department of Health and Human Services, Food and Drug Administration, Medical Devices; Exemptions From Premarket Notification and Reserved Devices; Class I, Docket No. 98N-0009, published in Federal Register, February 2, 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 February 2, 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 in-vitro diagnostic 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 supports and concurs with the FDA's decision to place a number of medical devices on the list of Reserved Class I Devices (Table - I). However, the ASM believes the current list of Reserved Class I Devices is incomplete.

The ASM recommends the FDA remove eleven (11) Class I devices from the list (Table 2) of exempted Class I devices and place them on the Reserved Class I Devices list (Table 1). After careful consideration and review, the ASM believes if the FDA exempts the following eleven in-vitro diagnostic devices it will pose serious public health hazards and therefore, these serological reagents and in-vitro diagnostic devices should not be exempt from Class I pre-market notification. Some of the serological reagents and in-vitro diagnostic devices placed in Table II are used to detect and diagnose high risk infectious diseases and therefore do meet the reserved criteria under section 206 of the Food and Drug Administration Modernization Act of 1997 and therefore should not be exempt from premarket notification.

The following serological reagents and in-vitro diagnostic devices fail to meet the criteria for exemptions as described in the regulatory notice as 'Limitations on Exemptions'. The following reagents and in-vitro diagnostic devices are used to or assist in the screening, diagnosis, and monitoring of life threatening diseases and misdiagnosis as a result of using these devices could be associated with high morbidity or mortality. In addition, the following in-vitro devices and serological reagents "(f) infer the identity of a microorganism directly from clinical material" or are used "(g) in the detection of antibodies to microorganisms". These two criteria are listed in the regulatory notice as indicators for placement on the Reserved Class I Devices list.

The ASM recommends that FDA remove the following from the list of Exempted Class I Devices and place them on the Reserved Class I Devices list.

864.2280 Cultured animal and human cells
Human and animal tissue culture cells are widely used in clinical microbiology laboratories to diagnose viral infections ranging from herpes simplex virus to influenza virus and enteroviruses. It is important that these cells be screened for susceptibility to viral infection and, particularly for animal cells, that they are free of indigenous viruses or other potentially inhibitory substances. The use of this in-vitro device "infers the identity of a microorganism directly from clinical material" and should therefore be removed from the list of exempted devices.

866. 2660 Microorganism differentiation and identification device
These devices are critical for conducting epidemiological studies and comparing results between laboratories. The use of these devices contribute to monitoring and surveillance of infectious diseases and the use of antimicrobial therapy.

866.3145 Coxsackievirus serological reagents
866.3240 Equine encephalomyelitis virus serological reagents
866.3360 Lymphocytic choriomeningitis virus serological reagents
866.3380 Mumps virus serological reagents
866.3405 Poliovirus serological reagents

The above serological reagents are used to detect viral infections in patients. The clinical laboratory professional relies on these reagents to diagnose serious viral infections which in some cases require appropriate anti-viral therapy. These viruses are difficult to culture and pose a serious challenge for the clinical laboratory professional. Misdiagnosis could seriously impact patient health and could cause inappropriate treatment, including unnecessary anti-viral therapy. In the case of coxsackie virus, this can lead to infection of the pericardium and sometimes death. These serological reagents are used in keys tests for identifying these viruses in tissue culture, and confirming these infections. The above and below serological reagents are all used "(g) in the detection of antibodies to microorganisms" and should therefore be placed on the Reserved Class I Devices list and should not be exempt from Class I review.

866.3200 Echinococcus spp. serological reagents
866.3850 Trichinella spiralis serological reagents

These two serological reagents are used to detect and diagnose parasitic infections. Tricinella is the cause of food borne trichinosis and muscle biopsy is much more costly and difficult.

866.3500 Rickettsia serological reagents
These organisms are difficult to culture and the clinical microbiologist depends on accurate serology to make the diagnosis. These reagents are also used when a public health outbreak investigation is conducted for these insect vector-borne organisms.

866.3740 Streptococcus spp. serological reagents
These reagents are critical to identify Group A Streptococcus when culture is not possible. For example, the reagent can be used to identify non-culturable group A strep infection which can cause acute glomerulonephritis, pharyngitis, or rheumatic fever.

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 eleven serological reagents and in-vitro diagnostic devices from the list of exempted Class I devices to protect the public health.

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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