---
kind: "section"
citation: "42 U.S.C. § 263a–2"
title: "42"
title_heading: "The Public Health and Welfare"
number: "263a–2"
heading: "Certification of embryo laboratories"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/263a-2"
units:
  - "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–2. Certification of embryo laboratories

- (a) **In general—**
  - (1) **Development—** Not later than 2 years after October 24, 1992, the [Secretary](/usc/42/201.md?p=c), through the Centers for Disease Control, shall develop a model [program](/usc/42/274l–1.md?p=4) for the certification of [embryo laboratories](/usc/42/263a–7.md?p=2) (referred to in this section as a “certification [program](/usc/42/274l–1.md?p=4)”) to be carried out by the [States](/usc/42/201.md?p=f).
  - (2) **Consultation—** In developing the certification [program](/usc/42/274l–1.md?p=4) under [paragraph (1)](#a-1), the [Secretary](/usc/42/201.md?p=c) shall consult with appropriate consumer and professional organizations with expertise in using, providing, and evaluating professional [services](/usc/42/201.md?p=a) and [embryo laboratories](/usc/42/263a–7.md?p=2) associated with the [assisted reproductive technology](/usc/42/263a–7.md?p=1) [programs](/usc/42/274l–1.md?p=4).
- (b) **Distribution—** The [Secretary](/usc/42/201.md?p=c) shall distribute a description of the certification [program](/usc/42/274l–1.md?p=4) to—
  - (1) the Governor of each [State](/usc/42/201.md?p=f),
  - (2) the presiding officers of each [State](/usc/42/201.md?p=f) legislature,
  - (3) the public health official of each [State](/usc/42/201.md?p=f), and
  - (4) the official responsible in each [State](/usc/42/201.md?p=f) for the operation of the [State](/usc/42/201.md?p=f)’s contract with the [Secretary](/usc/42/201.md?p=c) under [section 1395aa of this title](/usc/42/1395aa.md),

  and shall encourage such officials to assist in the [State](/usc/42/201.md?p=f) adopting such [program](/usc/42/274l–1.md?p=4).

- (c) **Requirements—** The certification [program](/usc/42/274l–1.md?p=4) shall include the following requirements:
  - (1) **Administration—** The certification [program](/usc/42/274l–1.md?p=4) shall be administered by the [State](/usc/42/201.md?p=f) and shall provide for the inspection and certification of [embryo laboratories](/usc/42/263a–7.md?p=2) in the [State](/usc/42/201.md?p=f) by the [State](/usc/42/201.md?p=f) or by approved accreditation organizations.
  - (2) **Application requirements—** The certification [program](/usc/42/274l–1.md?p=4) shall provide for the submission of an application to a [State](/usc/42/201.md?p=f) by an [embryo laboratory](/usc/42/263a–7.md?p=2) for certification, in such form as may be specified by the [State](/usc/42/201.md?p=f). Such an application shall include—
    - (A) assurances satisfactory to the [State](/usc/42/201.md?p=f) that the [embryo laboratory](/usc/42/263a–7.md?p=2) will be operated in accordance with the standards under [subsection (d)](#d),
    - (B) a report to the [State](/usc/42/201.md?p=f) identifying the [assisted reproductive technology](/usc/42/263a–7.md?p=1) [programs](/usc/42/274l–1.md?p=4) with which the laboratory is associated, and
    - (C) such other information as the [State](/usc/42/201.md?p=f) finds necessary.

    An [embryo laboratory](/usc/42/263a–7.md?p=2) which meets the requirements of [section 263a of this title](/usc/42/263a.md) shall, for the purposes of [subparagraph (A)](#c-2-A) be considered in compliance with the standards referred to in such subparagraph which are the same as the standards in effect under [section 263a of this title](/usc/42/263a.md).

- (d) **Standards—** The certification [program](/usc/42/274l–1.md?p=4) shall include the following standards developed by the [Secretary](/usc/42/201.md?p=c):
  - (1) A standard to assure consistent performance of procedures by each [embryo laboratory](/usc/42/263a–7.md?p=2) certified under the certification [program](/usc/42/274l–1.md?p=4) or by an approved accreditation organization in a [State](/usc/42/201.md?p=f) which has not adopted the certification [program](/usc/42/274l–1.md?p=4).
  - (2) A standard for a quality assurance and a quality control [program](/usc/42/274l–1.md?p=4) to assure valid, reliable, and reproduceable[^1] procedures in the laboratory.
  - (3) A standard for the maintenance of records (on a [program](/usc/42/274l–1.md?p=4) by [program](/usc/42/274l–1.md?p=4) basis) on laboratory tests and procedures performed, including the scientific basis of, and the methodology used for, the tests, procedures, and preparation of any standards or controls, criteria for acceptable and unacceptable outcomes, criteria for sample rejection, and procedures for safe sample [disposal](/usc/42/2021b.md?p=7).
  - (4) A standard for the maintenance of written records on personnel and facilities necessary for proper and effective operation of the laboratory, schedules of preventive maintenance, function verification for equipment, and the release of such records to the [State](/usc/42/201.md?p=f) upon demand.
  - (5) A standard for the use of such personnel who meet such qualifications as the [Secretary](/usc/42/201.md?p=c) may develop.
- (e) **Certification under State programs—** A [State](/usc/42/201.md?p=f) may qualify to adopt the certification [program](/usc/42/274l–1.md?p=4) if the [State](/usc/42/201.md?p=f) has submitted an application to the [Secretary](/usc/42/201.md?p=c) to adopt such [program](/usc/42/274l–1.md?p=4) and the [Secretary](/usc/42/201.md?p=c) has approved the application. Such an application shall include—
  - (1) assurances by the [State](/usc/42/201.md?p=f) satisfactory to the [Secretary](/usc/42/201.md?p=c) that the certification [program](/usc/42/274l–1.md?p=4) within the [State](/usc/42/201.md?p=f) meets the requirements of this section,
  - (2) an agreement to make such reports as the [Secretary](/usc/42/201.md?p=c) may require, and
  - (3) information about any proposed use of accreditation organizations under [subsection (g)](#g).[^2]
- (f) **Use of accreditation organizations—** A [State](/usc/42/201.md?p=f) which has adopted the certification [program](/usc/42/274l–1.md?p=4) may use accreditation organizations approved under [section 263a–3 of this title](/usc/42/263a–3.md) to inspect and certify [embryo laboratories](/usc/42/263a–7.md?p=2).
- (g) **Inspections—**
  - (1) **In general—** A [State](/usc/42/201.md?p=f) which qualifies to adopt the certification [program](/usc/42/274l–1.md?p=4) within the [State](/usc/42/201.md?p=f) shall conduct inspections in accordance with [paragraph (2)](#g-2) to determine if laboratories in the [State](/usc/42/201.md?p=f) meet the requirements of such [program](/usc/42/274l–1.md?p=4). Such inspections shall be carried out by the [State](/usc/42/201.md?p=f) or by accreditation organizations used by the [State](/usc/42/201.md?p=f) under [subsection (g)](#g).[^2]
  - (2) **Requirements—** Inspections carried out under [paragraph (1)](#g-1) shall—
    - (A) be periodic and unannounced, or
    - (B) be announced in such circumstances as the [Secretary](/usc/42/201.md?p=c) determines will not diminish the likelihood of discovering deficiencies in the operations of a laboratory.

    Before making a determination under [subparagraph (B)](#g-2-B), the [Secretary](/usc/42/201.md?p=c) shall make public, in such manner as to facilitate comment from any person (including any Federal or other [public agency](/usc/42/11851.md?p=8)), a proposal indicating the circumstances under which announced inspections would be permitted.

  - (3) **Results—** The specific findings, including deficiencies, identified in an inspection carried out under [paragraph (1)](#g-1) and any subsequent corrections to those deficiencies shall be announced and made available to the public upon request beginning no later than 60 days after the date of the inspection.
- (h) **Validation inspections—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c) may enter and inspect, during regular hours of operation, [embryo laboratories](/usc/42/263a–7.md?p=2)—
    - (A) which have been certified by a [State](/usc/42/201.md?p=f) under the certification [program](/usc/42/274l–1.md?p=4), or
    - (B) which have been certified by an accreditation organization approved by the [Secretary](/usc/42/201.md?p=c) under [section 263a–3 of this title](/usc/42/263a–3.md),

    for the purpose of determining whether the laboratory is being operated in accordance with the standards in [subsection (d)](#d).

  - (2) **Access to facilities and records—** In conducting an inspection of an [embryo laboratory](/usc/42/263a–7.md?p=2) under [paragraph (1)](#h-1), the [Secretary](/usc/42/201.md?p=c) shall have access to all facilities, equipment, materials, records, and information which the [Secretary](/usc/42/201.md?p=c) determines is necessary to determine if such laboratory is being operated in accordance with the standards in [subsection (d)](#d). As part of such an inspection, the [Secretary](/usc/42/201.md?p=c) may copy any material, record, or information inspected or require it to be submitted to the [Secretary](/usc/42/201.md?p=c). Such an inspection may be made only upon the presentation of identification to the [owner](/usc/42/13641.md?p=4), operator, or agent in charge of the laboratory being inspected.
  - (3) **Failure to comply—** If the [Secretary](/usc/42/201.md?p=c) determines as a result of an inspection under [paragraph (1)](#h-1) that the [embryo laboratory](/usc/42/263a–7.md?p=2) is not in compliance with the standards in [subsection (d)](#d), the [Secretary](/usc/42/201.md?p=c) shall—
    - (A) notify the [State](/usc/42/201.md?p=f) in which the laboratory is located and, if appropriate, the accreditation organization which certified the laboratory,
    - (B) make available to the public the results of the inspection,
    - (C) conduct additional inspections of other [embryo laboratories](/usc/42/263a–7.md?p=2) under [paragraph (1)](#h-1) to determine if—
      - (i) such [State](/usc/42/201.md?p=f) in carrying out the certification [program](/usc/42/274l–1.md?p=4) is reliably identifying the deficiencies of such laboratory, or
      - (ii) the accreditation organization which certified such laboratories is reliably identifying such deficencies,[^3] and
    - (D) if the [Secretary](/usc/42/201.md?p=c) determines—
      - (i) that such [State](/usc/42/201.md?p=f) in carrying out the certification [program](/usc/42/274l–1.md?p=4) has not met the requirements applicable to such [program](/usc/42/274l–1.md?p=4), or
      - (ii) the accreditation organization which certified such laboratory has not met the requirements of [section 263a–3 of this title](/usc/42/263a–3.md),

    the [Secretary](/usc/42/201.md?p=c) may revoke the approval of the [State](/usc/42/201.md?p=f) certification [program](/usc/42/274l–1.md?p=4) or revoke the approval of such accreditation organization.

- (i) **Limitation—**
  - (1) **Secretary—** In developing the certification [program](/usc/42/274l–1.md?p=4), the [Secretary](/usc/42/201.md?p=c) may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in [assisted reproductive technology](/usc/42/263a–7.md?p=1) [programs](/usc/42/274l–1.md?p=4).
  - (2) **State—** In adopting the certification [program](/usc/42/274l–1.md?p=4), a [State](/usc/42/201.md?p=f) may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in [assisted reproductive technology](/usc/42/263a–7.md?p=1) [programs](/usc/42/274l–1.md?p=4).
- (j) **Term—** The term of a certification issued by a [State](/usc/42/201.md?p=f) or an accreditation organization in a [State](/usc/42/201.md?p=f) shall be prescribed by the [Secretary](/usc/42/201.md?p=c) in the certification [program](/usc/42/274l–1.md?p=4) and shall be valid for a period of time to be defined by the [Secretary](/usc/42/201.md?p=c) through the public comment process described in [subsection (h)(2)](#h-2).[^4] The [Secretary](/usc/42/201.md?p=c) shall provide an application for recertification to be submitted at the time of changes in the ownership of a certified laboratory or changes in the administration of such a laboratory.

## Footnotes

[^1]: So in original. Probably should be “reproducible”.
[^2]: So in original. Probably should be subsection “(f)”.
[^3]: So in original. Probably should be “deficiencies,”.
[^4]: So in original. Probably should be subsection “(g)(2)”.

## Source credit

(Pub. L. 102–493, § 3, Oct. 24, 1992, 106 Stat. 3146.)

## Notes

### 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

### Change of Name

Centers for Disease Control changed to Centers for Disease Control and Prevention by Pub. L. 102–531, title III, § 312, Oct. 27, 1992, 106 Stat. 3504.

### 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.