StacksVerified U.S. regulatory reference

42 CFR §493.51

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
Laboratories issued a certificate of compliance must meet the following conditions:
  1. (a)Notify HHS or its designee within 30 days of any change in—
    1. (1)Ownership;
    2. (2)Name;
    3. (3)Location;
    4. (4)Director; or
    5. (5)Technical supervisor (laboratories performing high complexity only).
  2. (b)Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory's certificate of compliance, so that compliance with requirements can be determined.
  3. (c)Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance.