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 major regulatory science gaps and challenges that drive the Emergency Preparedness Program are:
- Lack of standardized methods for the assessment of personal protective equipment (PPE) shelf-life
- Lack of information about pediatric infection of pandemic pathogens that halts innovation and emergency response
- Lack of a methods for the assessment of antimicrobial PPE
- Lack of a guidelines to clean and sanitize PPE sufficiently in pandemic situations
- Lack of methods for assessment of additively manufactured medical products used in emergencies, including PPE
- Lack of methods for assessment of mask and respirator fit to improve performance and reduce leakage
Emergency Preparedness Program Activities
The Emergency Preparedness Program focuses on regulatory science research in these areas:
- Protocols for assessing technological features of pediatric facemask
- Additive Manufacturing verification methods for medical countermeasures
- Risk Calculators for Personal Protective Equipment (PPE)
- Material science frameworks for accelerated aging of PPE
For more information, email OSEL_emergencypreparedness@fda.hhs.gov.