Defending substantial equivalence: an argument for the continuing validity of the 510(k) premarket notification process.
Flaherty
James M
JM
Foley Hoag LLP, Boston, Massachusetts, USA.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D004864:Equipment and Supplies / Q000145:classification*; D033161:Government Regulation / Q000266:history; D049673:History, 20th Century; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration