FDA Research - Pediatric and Perinatal Devices

Organization

U.S. Food and Drug Administration (FDA)

FDA-CDRH-

9/30/2027 3:00:00 PM Eastern Time Zone

Applications will be reviewed on a rolling-basis.

15 research opportunities are available immediately with the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), located in Silver Spring, Maryland. Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration are educational training programs designed to provide students and recent graduates opportunities to participate in project-specific research and development at the Center for Devices and Radiological Health (CDRH).

The mission of CDRH is to protect and promote public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH provides consumers, patients, caregivers, and providers with understandable and accessible science-based information about products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

The Pediatric and Perinatal Devices Program within the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research aimed at advancing the development and evaluation of medical devices for pediatric and perinatal populations. This research initiative focuses on developing and validating specialized tools to assess device performance in conditions unique to pediatric and perinatal care. Such tools include non-clinical testing methods, curated datasets, physical phantoms, and computational models.

By addressing gaps in existing evaluation approaches, the program seeks to improve regulatory decision-making and facilitate the timely availability of appropriately designed medical devices for these vulnerable populations.

• Learn to conduct regulatory science research within the FDA’s Center for Devices and Radiological Health (CDRH), focused on pediatric and perinatal medical devices.
• Gain experience developing and validating specialized evaluation tools to assess device performance in pediatric and perinatal care settings.
• Develop skills in designing non-clinical testing methods, including the creation and use of curated datasets, physical phantoms, and computational models.
• Learn to identify and address gaps in current device evaluation approaches specific to pediatric and perinatal populations.
• Contribute to improving regulatory decision-making by generating evidence that supports the safe and effective use of medical devices in vulnerable populations.
• Strengthen understanding of the regulatory framework guiding the development and evaluation of pediatric and perinatal medical devices.

Matthew Hirschhorn (Matthew.Hirschhorn.gov)

• Anticipated Appointment
  
  Start Date:
  
  2026/2027. Start date is flexible and will depend on a variety of factors.
• Appointment Length:
  The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
• Level of Participation:
  Full time.
• Participant Stipend:
  The participant will receive a monthly stipend commensurate with educational level and experience.
• Citizenship Requirements:
  This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.
• Background Investigation:
  Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded  can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five…