Regulation Text
(a) Accreditation bodies submitting applications or renewal applications for recognition in the third-party certification program;
(b) Recognized accreditation bodies participating in the third-party certification program;
(c) Third-party certification bodies submitting applications or renewal applications for direct accreditation; and
(d) Accredited third-party certification bodies (whether accredited by recognized accreditation bodies or by FDA through direct accreditation) participating in the third-party certification program.
Authority
15 U.S.C. 1333,1453,1454,1455,4402;19 U.S.C. 1490,1491;21 U.S.C. 321,331,332,333,334,335a,342,343,350c,350d,350j,352,355,360b,360ccc,360ccc-1,360ccc-2,362,371,374,381,382,384a,387,387a,387c,393, and2223;42 U.S.C. 216,241,243,262,264,271.