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 ^_^

 

 

References

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.

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!