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  4. Medical Device Regulatory Science Research Programs Conducted by OSEL
  5. Pediatric and Perinatal Devices Program: Research of Pediatric and Perinatal Devices
  1. Medical Device Regulatory Science Research Programs Conducted by OSEL

Pediatric and Perinatal Devices Program: Research of Pediatric and Perinatal Devices

The Pediatric and Perinatal Devices Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patients have access to innovative medical devices used in pediatrics and during the perinatal stages that are safe and effective. This is one of the active research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).

Pediatric and Perinatal Medical Devices 

Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21. Devices used during perinatal stages cover the periods of time including pregnancy and childbirth. Some products are designed specifically for children, while others are borrowed from adult applications or produced for more general use. Designing pediatric medical devices can be challenging: children are often smaller and more active than adults, body structures and functions change throughout childhood, and children may be long-term device users. -- These considerations may raise additional concerns about device longevity and long-term exposure to implanted materials.

FDA is committed to supporting the development and availability of safe and effective medical devices.  The Pediatric and Perinatal Devices Program aims to directly support this commitment by developing testing methods and approaches that facilitate assessment of medical devices intended for use in the pediatric population and during the perinatal stages for their safety and/or effectiveness 

Regulatory Science Gaps and Challenges

Major regulatory science gaps and challenges that drive the Pediatric and Perinatal Devices Program are:

  • Limited number of medical devices indicated for pediatric and perinatal populations
  • Lack of test methods that evaluate the specific needs of the patients (e.g., growth)
  • Lack of readily-available information (e.g., clinical data) to facilitate proper sizes and designs of medical devices 
  • Lack of tools to reduce the cost of medical device development and testing

Pediatric and Perinatal Medical Devices Program Activities

The Pediatric and Perinatal Devices Program focuses on regulatory science research to develop tools that are targeted for the assessment and specific conditions related to pediatric and perinatal devices. These tools may include non-clinical testing methods, datasets, phantoms, and/or computational models. 

For more information, email contact: OSEL_pediatric@fda.hhs.gov

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