Regulatory Focus™ > News Articles > Looking to Enhance Patient Safety, FDA Finalizes Pediatric Information Rule for Devices

Looking to Enhance Patient Safety, FDA Finalizes Pediatric Information Rule for Devices

Posted 09 January 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has issued a final rule requiring sponsors of medical device applications to submit data on pediatric patients as a condition of approval.


The regulation was first issued in draft form in February 2013 under the terms of a 2007 law known as the Food and Drug Administration Amendments Act (FDAAA). The safety-focused legislation had contained a provision, Section 515A, which required any sponsor of a premarket approval application (PMA), PMA supplement, humanitarian device exemption (HDE) or product development protocol (PDP) to submit to FDA information regarding how many children suffer from the disease their product is intended to treat.

Pediatric populations, however, are not lumped together as just "anyone under the age of 18." Rather, there are distinguishable subpopulations. FDA defines pediatric populations as including neonates (0-28 days), infants (<2 years), children (2-12 years of age) and adolescents under 21 years of age. In other words, if a product can treat a person under the age of 21, it falls under section 515A of FDAAA.

In particular, the law wants two pieces of information from companies:

  1. a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure
  2. the number of affected pediatric patients

Why the Rule?

The goal of section 515A is relatively straightforward: Products that are likely to be used by children should be able to be used safely by them. Safe use provisions require data. Therefore, companies should obtain data.

The logic seems simple enough, and there's ample precedence for similar actions within the pharmaceutical products space, where several laws have required companies to collect data on pediatric use. But companies have not traditionally been eager to test their products on children, primarily for ethical or market-based reasons. Children, in addition to having smaller bodies, usually have smaller market sizes as well, and no one wants to conduct a study in which a device contributes to the death or suffering of a child.

Companies, then, are in need of some prodding, which is where Section 515A comes into play.

Readily Available Information

Under the now-final regulation, companies will need to include any descriptions of any pediatric populations that suffer from the disease that the device is intended to treat, diagnose, or cure. The caveat is that such information must be "readily available"-an addition intended to prevent companies from needing to extensively seek out non-obvious patients.

What is "readily available" information? FDA said industry should stay tuned for an accompanying guidance document that will explain that definition and how to comply with the regulation.

A draft guidance released last year, however, defined the term as being any information "available in the public domain."

The earlier draft guidance provided an example of the information companies would need to include, as well as the format for submission:

Example of Pediatric Summary Table


Pediatric Incidence

Pediatric Prevalence

Pediatric subpopulation /
age range

Specific device /


This device is indicated for use as an adjunct to medical therapy in the management of pediatric and adult patients with the following clinical conditions:
Congestive heart failure related to rare congenital disease, e.g., Duchenne's muscular dystrophy



Adolescent 16-21

Widget Model M-111

Harsh Consequences for Failure to Comply

Consequences of not producing pediatric information are harsh.

For sponsors, the penalties are potentially severe and indirectly costly. "If the applicant does not submit the information required by section 515A(a) of the FD&C Act, FDA may not approve the application until the applicant provides the required information," FDA explained.

If FDA finds that an application is missing the pediatric section during the course of its normal review, it says it will contact the applicant and ask it to amend the application to include the required information.

If FDA does not detect this omission until the end of the review, it said it would send sponsors an "approvable letter" placing final approval on hold until section 515A data is submitted to the agency for review.

Sponsors with other deficiencies that could still obtain approval will be sent a "major deficiency" letter explaining the effect of the missing 515A data in addition to other deficiencies, FDA said.

The rule goes into effect in 90 days, FDA said.

Medical Devices; Pediatric Uses of Devices: Requirement for Submission of Information on Pediatric Subpopulations that Suffer from a Disease or Condition that a Device is Intended to Treat, Diagnose, or Cure

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