United States Code (Last Updated: May 24, 2014) |
Title 42. THE PUBLIC HEALTH AND WELFARE |
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. Certification revocation and suspension
Latest version.
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(a) In general 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) Effect 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.
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.
Effective Date
Section effective upon expiration of 2 years after