Office of Readiness and Response
Who We Are
The Office of Readiness and Response (ORR) provides leadership and strategic direction on medical device cybersecurity and standards while providing oversight and coordination related to public health emergency preparedness. ORR is within CDRH’s Office of Strategic Partnership and Technology Innovation (OST).
What We Do
- Provide leadership, oversight, and coordination in matters relating to emergency preparedness and response involving the CDRH-regulated products or facilities.
- Provide global leadership and innovation in standards implementation and utilization for medical device development and manufacturing and radiation-emitting product safety.
- Provide leadership and strategic direction on the cybersecurity of medical devices.
Office of Readiness and Response
- Division of All Hazards Preparedness and Response
- Division of Standards and Conformity Assessment
- Division of Medical Device Cybersecurity
Division of All Hazards Preparedness and Response
Who We Are
The Division of All Hazards Preparedness and Response provides leadership for emergency preparedness and response and medical-countermeasures regulatory science.
What We Do
- Advance national preparedness, coordination, and response for all hazards threats, including but not limited to chemical, biological, radiological, nuclear, explosive (CBRNE), emerging infectious diseases, and natural disasters while enhancing collaborations, optimizing operational responsiveness, and leveraging CDRH regulatory science capabilities via an integrated approach.
- Expand the breadth and depth of regulatory science knowledge and expertise that will inform safety and effectiveness evaluation of medical countermeasure (MCM) assets critical for deployment before and during a public health incident and facilitates the timely review of all MCM medical devices and diagnostics in CDRH’s MCM portfolio.
Division of Standards and Conformity Assessment (DSCA)
Who We Are
The Division of Standards and Conformity Assessment provides leadership for standards development and implementation.
What We Do
- Produces and implements clear policies to promote the appropriate use of standards in regulatory processes
- Anticipates the need for and leads the development of national and international consensus standards
- Advances initiatives to enhance confidence in conformity assessment activities
- Fosters innovation and standardization in technologies that facilitate patient access to novel devices
- Provides leadership in standards quality and utilization through outreach and global harmonization
Division of Medical Device Cybersecurity (DMDC)
Who We Are
The Division of Medical Device Cybersecurity provides leadership and strategic direction for medical device cybersecurity policy.
What We Do
- Lead and collaboratively advance the cybersecurity posture of the Healthcare and Public Health (HPH) critical infrastructure medical device ecosystem via a total product lifecycle (TPLC) approach, furthering the development and implementation of policy and strategic engagements.
- Advance national preparedness, response and coordination for cybersecurity incidents involving medical devices by enhancing collaborations, optimizing operational responsiveness, and leveraging CDRH regulatory science capabilities via an integrated approach.
Contact Us
For specific phone numbers and email addresses for each office, division, and team, see the CDRH Management Directory by Organization.
For general questions about medical devices regulation, contact the Division of Industry and Consumer Education at dice@fda.hhs.gov or 800.638.2041 or 301.796.7100.