FDA issues guidance on "child" definition for PMAs (Pre-market Approvals):
This article was originally published in Clinica
The FDA has issued a final guidance on premarket submissions for devices intended for children. Initially released in draft form in July 2003, the revised document now clarifies the distinction between state and federal law pertaining to the age of consent to the clinical definition of the paediatric population. It continues to define adolescent as aged 12 to 21, even though some paediatric devices include labelling that puts the upper age limit for a child at age 18. The FDA explained that its age descriptions are somewhat arbitrary, and that other factors, such as the weight, body size and physiological and neurological development, may be more appropriate indicators.