§263a–4 — Title 42 The Public Health and Welfare | U.S. Code

§263a–4 Certification revocation and suspension

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

Last updated Apr 6, 2026|Official source

Summary

A State or an accrediting group must revoke or suspend an embryo lab’s certification if, after inspections and after giving the lab notice and a chance for a hearing, it finds that the lab owner, operator, or any employee lied to get the certification, failed to follow the required standards, or refused to let inspectors examine the lab, its operations, and records. If a certification is revoked or suspended, it still stays in effect for 60 days after the lab gets notice. The lab can only apply for recertification one year after the date of the revocation or suspension.

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.

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.