On Friday, January 10, 2014 the FDA issued a final rule, which amends the premarket approval (PMA) regulations. The final rule requires “submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat”. 1 The final rule also defines “pediatric patients” and “pediatric subpopulations”. Per the final rule, “pediatric patients” is defined as a patient who is 21 years old or younger at the time of treatment or diagnosis. “Pediatric subpopulation” means on for the following populations: neonate, infants, children, or adolescents.

Other applications that are subject to the final rule include:

  • Humanitarian Device Exemption (HDE)
  • Premarket Approval Application (PMA) or supplement to a PMA
  • Product Development Protocol (PDP)

The final rule requires the submission of the following:

  • readily available information on the pediatric subpopulation(s) the device is intended for
  • description of the pediatric subpopulation(s) that suffers from the target disease of condition
  • # of affected pediatric patients

How will this final rule help the industry? What potential roadblocks may be ahead? I want to know your thoughts regarding the final rule! Please leave your comments below. For additional information, please visit the Federal Register.


-RSpelich ^_^




1.) FDA and HHS. Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure, Part --- (Final Rule). Federal Register 79;7 (10 Jan. 2014) p.1735. Available at: http://www.gpo.gov/fdsys/pkg/FR-2014-01-10/pdf/2014-00267.pdf. Accessed on 14 Jan. 2014.

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