The Emergency Preparedness Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patient access to innovative emergency preparedness devices that are safe and effective. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).

Emergency Preparedness and Medical Devices

Emergency situations can arise without warning and may require the rapid evaluation of medical devices. The FDA relies on standardized assessment methods to evaluate the effectiveness of medical devices for emergencies, so patients have access to safe and high-quality devices.

The FDA should ensure preparedness for emerging needs of the nation. Despite the increased use of regulatory science tools, currently there are few regulatory tools specific for the rapid and effective evaluation of common risks associated with the use of medical devices for emergency response.

Regulatory Science Gaps and Challenges

The Emergency Preparedness Program focuses on regulatory science research in these areas:

• Lack of information about pediatric infection of pandemic pathogens that halts innovation and emergency response. For example, it is critical to understand leakage and fit of FDA-regulated pediatric facemasks using pediatric models.
• Lack of a general risk assessment model that can be rapidly calibrated for new pathogens.
• Lack of a standardized in silico methodology to perform fit testing of 3D-printed respiratory protective devices for the general population during a public health emergency.
• Lack of a repository of filtration of barrier materials, including simplified, generic, and easy-to-perform risk assessment approaches to determine risk of filtration of home-based fabrics.
• Lack of a guidelines to clean and sanitize face masks sufficiently in pandemic situations. Simple verification tasks should be created to ensure the process has a reasonable degree of confidence.

Emergency Preparedness Program Activities

The Emergency Preparedness Program focuses on regulatory science research in these areas:

• Assessment of priorities for current and potential medical countermeasures
• Development of alternative assessment tools for emergency situations, including:
  • Additive Manufacturing Framework for Crisis Response
  • Risk Calculators for Personal Protective Equipment (PPE)
  • Highly Adaptive Risk Assessment Model
  • Rapid Evaluation Tools for Do-It-Yourself Masks
  • In Silico Fit Testing of 3D-Printed Facemasks

For more information, email [email protected].