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FY 2001 ODE Annual Report - Part 4 — Major Program Initiatives

Bioterrorism Preparedness

Genetics Testing

Bioterrorism Preparedness

ODE is currently involved in several resource-intense initiatives related to national bioterrorism preparedness and response. ODE established liaison and collaboration with other government agencies and the military to prepare for regulatory responsibilities applicable to in vitro diagnostic products and other medical devices that are critical to bioterrorism preparedness efforts. ODE is also developing a pool of expert reviewers to meet the expected demands related to timely premarket review and approval of these devices.

Although ODE has been involved in CDRH bioterrorism preparedness activities in the past, during this fiscal year our involvement intensified to the point that it has become a major program initiative. These activities cover several ODE divisions and different aspects of the problem.

The Division of Clinical Laboratory Devices (DCLD) formed the DCLD IVD Chem-Bioterrorism preparedness Working Group to develop a clear interpretation of the IVD regulations for supporting CDC's and the military's bioterrorism preparedness activities. The medical and public health preparedness and response to bioterrorism threats include the identification of threat agents by using in vitro diagnostic devices. Most laboratory reagents and test kits used for the identification of threat agents are not routinely used in the clinical laboratory and have not been cleared or approved by FDA.

DCLD has been interacting with manufacturers involved in the development and data gathering on devices for the identification of bioterrorism threat agents. DCLD has met with several companies to clarify the premarket review requirements and routes available to obtain clearance or approval for medical uses. Our scientists have participated in discussions with industry, the CDC and the military in determining options for making new in vitro diagnostic devices available and in clarifying requirements for testing during the investigational phase of the products.

The Division of Dental, Infection Control, and General Hospital Devices (DDIGD) evaluated a modification of a device intended for use by the military to remove chemical agents from clothing and skin. It also began discussions with another applicant on a device intended for the same use but employing a different formulation. DDIGD evaluated submissions during the fiscal year on liquid chemical agents, ultraviolet light air purifiers, and sterilizers that could be used to decontaminate surfaces and products.

The Division of Cardiovascular and Respiratory Devices (DCRD) has been involved in the Ad Hoc Committee on Device Shortage for Bioterrorism Preparedness and Response. The Committee considered a list of devices that would be needed in the event of a chemical or biological attack.

POS is also involved in bioterrorism preparedness and response by providing support to the ODE Divisions that are directly involved. In particular, the IDE staff has been very helpful by providing guidance on difficult regulatory issues.


Genetics Testing

During FY O1, three agencies within HHS (the FDA, the Centers for Disease Control and Prevention (CDC), and the Center for Medicare and Medicaid Services (CMS)) have been collaborating on the Department's role in the oversight of genetic testing. In response to the Secretary's Advisory Committee on Genetic Testing (SACGT) recommendations, ODE's Division of Clinical Laboratory Devices has under development a "Genetics Template" which will serve as an outline for collecting administrative, analytical, and clinical data on tests used to detect the presence of genetic diseases. DCLD has been developing this template in collaboration with professional laboratory and clinical organizations. Additional steps for the potential oversight of genetic disease testing are still in the planning stages, but information collected in the templates could enable FDA to focus its attention to monitoring genetics testing activities.