Having a sick child can be one of the hardest jobs of parenting. Having a sick child that requires treatment and care beyond a quick visit to the local doctor or nurse, or light fluids and lots of rest can cause the worry to rise exponentially. And what if treatment involves a procedure involving an experimental medical device? A recent guidance published by the FDA on March 24, 2014 attempts to clarify the department’s thinking on how to effectively protect the pediatric population. This guidance comes after the FDA issued a finale rule on January 10, 2014 amending PMA regulations to require inclusion of information relating to pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure, and the number of affected pediatric patients. This guidance caps off a series of rules and guidance’s issued over the last 13 years when, in 2001, the FDA issued an interim rule to comply with the Children’s Health Act of 2000. This interim rule mandated that all pediatric research in the US offer additional protections to ensure pediatric patient safety.