Pediatric cardiac devices--an FDA pediatrician's perspective of the challenges and potential solutions.
The advancement of pediatric medical devices is an important challenge currently facing the Food and Drug Administration and the medical community. In this manuscript, the challenges are described and possible solutions presented.
Dolcimascolo
Francesca
F
FDA, Silver Spring, MD, USA. francesca.dolcimascolo@fda.hhs.gov
D002309:Cardiology / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D002648:Child; D002675:Child, Preschool; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence; D004867:Equipment Design; D004869:Equipment Safety; D019317:Evidence-Based Medicine; D033161:Government Regulation; D006291:Health Policy; D006801:Humans; D007223:Infant; D010372:Pediatrics / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D011356:Product Labeling; D018570:Risk Assessment; D014481:United States