21 C.F.R. § 1.700 – Who is subject to a user fee under this subpart?

(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.