Regulation Text
(a) [Reserved]
(b) Compliance with good manufacturing practices. In vitro diagnostic products shall be manufactured in accordance with the good manufacturing practices requirements found in part 820 of this chapter and, if applicable, with § 610.44 of this chapter .
Authority
21 U.S.C. 321(h)(1),331,351,352,360,360c,360d,360e,360h,360i,360j,371,372,374,381, and42 U.S.C. 262.