42 U.S. Code § 263a–4 - Certification revocation and suspension

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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.

Source

(Pub. L. 102–493, § 5,Oct. 24, 1992, 106 Stat. 3150.)
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 Oct. 24, 1992, see section 9 ofPub. L. 102–493, set out as a note under section 263a–1 of this title.

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21 CFR - Food and Drugs

21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS

21 CFR Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

21 CFR Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

21 CFR Part 600 - BIOLOGICAL PRODUCTS: GENERAL

21 CFR Part 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

21 CFR Part 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS

21 CFR Part 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS

42 CFR - Public Health

42 CFR Part 416 - AMBULATORY SURGICAL SERVICES

42 CFR Part 418 - HOSPICE CARE

42 CFR Part 491 - CERTIFICATION OF CERTAIN HEALTH FACILITIES

42 CFR Part 493 - LABORATORY REQUIREMENTS

 

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