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Title 42, The Public Health and WelfareRelease 119-73not60

§263a–4 Certification Revocation and Suspension

Title 42 › Chapter 6A— PUBLIC HEALTH SERVICE › Subchapter II— GENERAL POWERS AND DUTIES › Part F— Licensing of Biological Products and Clinical Laboratories › Subpart 2— clinical laboratories › § 263a–4

Last updated Apr 5, 2026|Official source

Summary

States or accrediting groups must revoke or suspend an embryo lab’s certification if, after inspections and a fair hearing, they find the owner, operator, or an employee lied to get it, failed to meet required standards, or blocked inspections or access to records. Certification stays in effect for 60 days after notice, and the lab may reapply one year after the revocation or suspension.

Full Legal Text

Title 42, §263a–4

The Public Health and Welfare, Source: USLM XML via OLRC

(a)A certification issued by a State or an accreditation organization for an embryo laboratory shall be revoked or suspended if the State or organization finds, on the basis of inspections and after reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that the owner or operator or any employee of the laboratory—
(1)has been guilty of misrepresentation in obtaining the certification,
(2)has failed to comply with any standards under section 263a–2 of this title applicable to the certification, or
(3)has refused a request of the State or accreditation organization for permission to inspect the laboratory, its operations, and records.
(b)If the certification of an embryo laboratory is revoked or suspended, the certification of the laboratory shall continue in effect for 60 days after the laboratory receives notice of the revocation or suspension. If the certification of an embryo laboratory is revoked or suspended, the laboratory may apply for recertification after one year after the date of the revocation or suspension.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Codification Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of Pub. L. 102–493, set out as a note under section 263a–1 of this title.

Reference

Citations & Metadata

Citation

42 U.S.C. § 263a–4

Title 42, The Public Health and Welfare

Last Updated

Apr 5, 2026

Release point: 119-73not60