Assessment of US pathway for approving medical devices for rare conditions.
Faculty of Arts and Sciences, Harvard University, Cambridge, MA 02138, USA.
Thomas J
TJ
Hwang
Daniel
D
Carpenter
Aaron S
AS
Kesselheim
D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D035583:Rare Diseases / Q000628:therapy*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*