FDA Guidance - Premarket Assessment of Pediatric Medical Devices (Draft)

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 (neonate)      from birth to 1 month of age
Infant                 greater than 1 month to 2 years of age
Child                  greater than 2 to 12 years of age
Adolescent             greater than 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.[5,6,7] 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.

[5] Berhman RE, Kliegman R, Arvin AM, Nelson WE. Nelson Textbook of Pediatrics, 15th Ed. Philadelphia: W.B. Saunders Company; 1996.

[6] Rudolph AM, et al. Rudolph’s Pediatrics, 21st Ed. New York: McGraw-Hill; 2002.

[7] Avery MD, First LR. Pediatric Medicine, 2nd Ed. Baltimore: Williams & Wilkins; 1994.

Additional pediatric subpopulations include:

- low birth weight describes newborns less than 2.5 Kg

- very low birth weight describes newborns less than 1.5 Kg

- preadolescent age group typically ranges from 11 to 13 years.

Although these pediatric subpopulations are not included in Table 1, device labeling and clinical studies should address, as applicable, any issues that pertain to these or other pediatric subpopulations, such as low birth weight newborns.

It is important to note the distinction between the clinical age limit of 21 described in this guidance and the legal age for consent. For the purposes of informed consent, manufacturers must comply with all federal and state regulations governing age and mental capacity.[9] A detailed discussion of informed consent issues as they pertain to the pediatric population is presented in Section X.