FDA is gold standard of review.
Mark B
MB
Leahey
D018795:Device Approval; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D008017:Life Expectancy; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*