1. 21 U.S.C. §§ 301 et seq.; 21 C.F.R. §§ 200–299 (Drug Regulations); 21 C.F.R. §§ 300–499 (human drug regulations); 21 C.F.R. §§ 600–799 (biological regulations); and 21 C.F.R. §§ 800–1299 (medical device regulations); see also Riegel v. Medtronic, 552 U.S. 352 (2008).
2. Goodman v. Sullivan, 891 F.2d 449, 451 (2d Cir. 1989) (The Medicare program was not obligated to cover a diagnostic test based only on the FDA’s approval of the test.).
3. CMS and FDA have started a pilot parallel review program under which a limited number of medical products would be considered by each agency simultaneously. 75 Fed. Reg. 57045 (2010) and 76 Fed. Reg. 62808 (2011).
4. See, for example, Hays v. Sebelius, 589 F.3d 1229 (D.C. Cir. 2009).
5. See Goodman, note 4, supra.