View all text of Subpart B [§ 493.35 - § 493.41]
§ 493.39 - Notification requirements for laboratories issued a certificate of waiver.
Laboratories performing one or more tests listed in § 493.15 and no others must notify HHS or its designee—
(a) Before performing and reporting results for any test or examination that is not specified under § 493.15 for which the laboratory does not have the appropriate certificate as required in subpart C or subpart D of this part, as applicable; and
(b) Within 30 days of any change(s) in—
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.