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Premarket Assessment of Pediatric Medical Devices

In that the FDA approves devices through the PMA, 510(k) and BLA methods, they provided this guidance document to assist in providing the necessary data to support these applications.

This guidance should be used in conjunction with other device-specific guidances to help ensure that medical devices intended for use in the pediatric population provide reasonable assurance of safety and effectiveness.

II. Objectives

1. To help define pediatric population and pediatric use for medical devices and device clinical trials.
2. To help identify the types of information needed to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in the pediatric population.
3. To help define the protections sponsors should consider for pediatric subjects in device clinical trials.

III. Pediatric Population and Use

A. Definition of Pediatric Population Subgroups

For purposes of this guidance, we are proposing the following ranges of pediatric subpopulations to be used as a guide for manufacturers in developing medical devices:

Table 1 Age Ranges of Pediatric Subgroups

Pediatric Subgroup	Approximate Age Range
Newborn	birth to 1 month of age
Infant	1 month to 2 years of age
Child	2 to 12 years of age
Adolescent	12 to 21 years of age

Although the upper age limit used to define the pediatric population varies among experts, including adolescents up to the age of 21 is consistent with the definition found in several sources.^1,2,3 Given the scope of medical devices and the impact that a device could have on a growing adolescent as well as the effect growth could have on the device, we believe that including the upper age limit identified above may be useful for some devices and device clinical trials. The agency recognizes, however, that the descriptions are somewhat arbitrary and that, in fact, the subject’s weight, body size, physiological development, neurological development, and neuromuscular coordination may often be more appropriate indicators than chronological age. In addition, when clinical trials are to be conducted, sponsors should consider the age of consent in the state(s) where the trial will be performed to determine the age range for the oldest subgroup.

Other terminology that describes subgroups in the pediatric population includes:

• - low birth weight describes babies less than 2.5 kilograms (Kg)
• - very low birth weight describes babies less than 1500 grams (g)
• - preadolescent age group typically ranges from 11 to 13 years.

The guidance document also addresses the following areas:

• Definition of Pediatric Use
• General Principles in Medical Device Evaluation
• Preclinical Studies
• Clinical Studies
  • Risk Assessment and Mitigation
  • Pediatric Subgroups
• Unique Host Characteristics
• Labeling
• Protections for Pediatric Populations in Clinical Trials

If you are contemplating developing a medical device for this population, this guidance document is critical.

For a copy of the entire document please go to the following website:
http://www.fda.gov/cdrh/mdufma/guidance/1220.html

The FDA is also looking for comments. Submit written comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Electronic comments can be submitted though the following website http://www.fda.gov/dockets/ecomments

If any questions please feel free to contact mdi at info@mdiconsultants.com

.S. AGENT SECTION

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