An assisted reproductive technology (ART) clinic compliance program is the calendar, procedures and records a fertility clinic uses to meet its federal duties: the annual report of pregnancy success rates to CDC under 42 U.S.C. 263a-1 and, for clinics that use donated eggs, sperm or embryos, the donor-eligibility rules in 21 CFR Part 1271, Subpart C. Integral Healthcare Solutions (IHS) drafts the reporting calendar, the cycle-tracking procedure, the laboratory file and the donor-file procedures for the clinic director to approve.
IHS is a consulting firm, not a law firm. Your counsel advises on legal duties and State law.
Last updated: November 2026
What does federal law require of an ART clinic?
Section 42 U.S.C. 263a-1(a) (page opened 2026-11-05) says each ART program "shall annually report to the Secretary through the Centers for Disease Control" the pregnancy success rates it achieved through each assisted reproductive technology, and the identity of each embryo laboratory it used and whether that laboratory is certified under section 263a-2 or has applied for certification.
Section 263a-1(b) leaves the definition of pregnancy success rates to the Secretary. It must include the basic live birth rate for each technology (pregnancies that result in live births divided by ovarian stimulation procedures attempted) and the live birth rate per successful oocyte retrieval procedure. IHS reads this to mean the data definitions come from CDC, not the clinic. Section 263a-7 defines assisted reproductive technology as "all treatments or procedures which include the handling of human oocytes or embryos," including in vitro fertilization.
Who reports, and who signs?
The program's Medical Director verifies and reports the cycle data. On the CDC National ART Surveillance System page (opened 2026-11-05, dated December 10, 2024), CDC says the Fertility Clinic Success Rate and Certification Act of 1992 "mandates that clinics performing ART annually provide data to CDC." The current requirements were published on August 26, 2015 (80 FR 51811), with six later notices through August 29, 2024 (89 FR 70189).
The 2015 notice defines an ART program as a practice, program or clinic meeting three criteria: it is a legal business entity that practices under State law; it is recognizable to the consumer as a stand-alone ART program or clinic, separate from another program with which it shares resources or liability; and it provides ART services to patients. The Medical Director in position at the reporting deadline is responsible for verifying and reporting all of the program's cycles for that reporting year. If the Medical Director is not available due to unforeseen circumstances, the Laboratory Director may assume that duty.
The program that accepts responsibility for the embryo culture reports the cycle, and the program that accepts responsibility for thawing reports cycles using previously cryopreserved oocytes or embryos.
When and how does a clinic report?
Per the 2015 notice, the deadline is December 15 of the year after the cycles were conducted, and CDC announces each deadline by letter 90 days before. Initial cycle intent and select patient details are due within four days of cycle initiation. Outcomes cannot be reported until about 9 to 10 months after the reporting year ends, per the CDC page.
The 2015 notice also requires records that link each patient, cycle, oocyte retrieved, transfer and pregnancy outcome. For reporting year 2025 the August 29, 2024 notice removes the research cycle study type and the dosage of long-acting FSH, and adds the date of fresh embryo cryopreservation for all frozen embryo transfers.
What happens if a clinic does not report?
Under the 2015 notice, a program is non-compliant if it was in operation during the reporting year, performed any ART cycles, and either fails to submit cycle data by the deadline or its Medical Director fails to verify the clinic success rates table by the deadline. These programs are identified as non-reporters. Section 263a-5 has CDC publish the name of each program that failed to report one or more rates, with each rate it failed to report.
CDC also checks the data. On its NASS data validation page (opened 2026-11-05, dated December 10, 2024), CDC says that in recent years about 35 reporting clinics (7% to 10%) have been selected for validation by stratified random sampling, with sampled cycles compared with the medical record. CDC says validation does not assess clinical practice or overall recordkeeping. The 2024 notice keeps removing the success rates of a selected clinic that declined to participate.
What does embryo laboratory certification involve?
Section 263a-2(a) directs the Secretary to develop a model program for the certification of embryo laboratories "to be carried out by the States." A State may qualify to adopt it by applying to the Secretary and receiving approval. Ask your State health department or counsel whether your State has adopted it. The CDC page says certification can currently be done by one of two nonfederal laboratory accreditation programs, one from the College of American Pathologists and one from the Joint Commission, and that CDC does not endorse them. IHS covers the first on its CAP reproductive laboratory accreditation page.
Where do FDA donor-eligibility rules fit?
Semen and other reproductive tissue are listed examples of human cells, tissues, and cellular and tissue-based products (HCT/Ps) in 21 CFR 1271.3. Section 1271.45(b) (eCFR text built November 4, 2026) requires a donor-eligibility determination for all donors of cells or tissue used in HCT/Ps, except as provided in 1271.90, and for an embryo requires one for both the oocyte donor and the semen donor. Under 1271.45(c) the product must not be implanted, transplanted, infused or transferred until the donor has been determined eligible, except as provided in 1271.60(d), 1271.65(b) and 1271.90.
Section 1271.90(a) removes the requirement for cells and tissue for autologous use and for reproductive cells or tissue donated by a sexually intimate partner of the recipient for reproductive use. Labeling requirements in 1271.90(c) apply to those products, as applicable. Narrower provisions in 1271.90(a)(3) and (a)(4) cover some cryopreserved material later donated, each with its own conditions.
Where a determination is required, a responsible person must determine and document eligibility (1271.50(a)). The donor specimen is collected at recovery or up to 7 days before or after, except that for oocyte donors collection may be up to 30 days before recovery, among other exceptions (1271.80(b)). Written procedures must be approved by a responsible person before implementation (1271.47). FDA registration, inspection and enforcement are not covered here.
Who needs it and what triggers it
- A new program starts to report.
- A director leaves, or ownership changes.
- The embryo laboratory changes.
- CDC selects the program for validation.
- The clinic begins donor egg, sperm or embryo cycles.
How IHS helps
Thomas G. Goddard, JD, PhD, IHS founder and former URAC Chief Operating Officer and General Counsel, leads the work. IHS runs three practice lines, Accreditation Consulting, Compliance Services and Program Development; this work is Compliance Services. For a broader build, see compliance program development.
The process
- Gap assessment against the statute, the CDC notices and the Part 1271 sections above.
- Evidence mapping of each requirement to the record that shows it.
- Drafting an annual reporting calendar, a cycle and outcome tracking procedure, a handover checklist for the Medical Director role, a laboratory verification file, donor-eligibility procedures and an audit-readiness file, for the clinic director to approve.
- Mock review of the finished file, with a list of what is missing.
You supply cycle and outcome records, laboratory contracts and certification status, EHR or registry exports, donor files, the names of your directors and account holder, and the CDC instructions you use today.
The real limit: IHS does not submit data to CDC, does not use your NASS account and does not contact CDC or FDA. IHS drafts; your clinic reports.
What to have ready
- The Medical Director and Laboratory Director names, with the dates each took the role.
- The NASS account holder, a backup, and the CDC deadline letter.
- Every ART cycle started in the reporting year, with its initiation date.
- Records linking each patient, cycle, oocyte retrieved, transfer and pregnancy outcome.
- Each embryo laboratory used, with its certification or application status (263a-1(a)(2)).
- Donor files and written donor-eligibility procedures, if you use donated material.
The free introductory call is where IHS walks through this list with you.
How it compares
| Regime | What it covers | On this page |
|---|---|---|
| 42 U.S.C. 263a-1 and CDC notices | Annual report of success rates and laboratory status | Read and mapped |
| 42 U.S.C. 263a-2 model certification | State-run embryo laboratory certification | Read; State adoption not researched |
| 21 CFR Part 1271, Subpart C | Donor eligibility | Key sections read |
| CAP laboratory accreditation | Laboratory inspection program | Separate IHS page |
| State rules for ART clinics and tissue banks | State licensure | Not researched |
What it costs
Section 263a-6 says the Secretary "may require the payment of fees for the purpose of, and in an amount sufficient to cover the cost of, administering sections 263a-1 to 263a-7." The CDC pages opened state no reporting fee. Verify current fees with CDC.
IHS scopes each engagement after a free introductory call. Scope moves with the number of sites and laboratories, the cycles you start each year, whether you use donated material and how far your records are from the sources above. Your staff time is separate.
What this is not
- It is not legal advice. IHS is a consulting firm, not a law firm.
- It is not laboratory certification or accreditation.
- It is not a guarantee of any result with CDC or FDA, and not clinical advice.
Frequently asked questions
What does 42 U.S.C. 263a-1 require of an ART clinic?
It requires each ART program to report annually to the Secretary through the Centers for Disease Control. The report covers the pregnancy success rates achieved through each technology, the identity of each embryo laboratory used, and whether that laboratory is certified under section 263a-2 or has applied for certification.
Who must report to CDC, and who signs the report?
An ART program, which the August 26, 2015 notice defines by three criteria listed above. The Medical Director in position at the reporting deadline verifies and reports the program's cycles for the reporting year. The Laboratory Director may assume that duty if the Medical Director is unavailable due to unforeseen circumstances.
When is the report due?
The 2015 notice sets December 15 of the year after the cycles were conducted. CDC's validation page says clinics submit by the deadline CDC announces each year, so confirm the current date.
What counts as a pregnancy success rate?
Section 263a-1(b) leaves the definition to the Secretary, and it must include the basic live birth rate for each technology and the live birth rate per successful oocyte retrieval procedure.
What must we record about our embryo laboratory?
Its identity and whether it is certified under section 263a-2 or has applied for certification, because the annual report asks for both. IHS drafts a verification file with a recheck trigger for laboratory changes.
What happens if a clinic does not report?
A program that was in operation and performed any ART cycles in the reporting year, and then either misses the submission deadline or has a Medical Director who does not verify the success rates table by the deadline, is identified as a non-reporter under the 2015 notice. Section 263a-5 has CDC publish the program's name and each rate it failed to report.
How does CDC check the data?
Each year CDC compares sampled cycles at a stratified random sample of reporting clinics with the medical record. It says validation does not assess clinical practice or overall recordkeeping. A selected clinic that declines has its success rates removed from the annual report.
Do the FDA donor-eligibility rules apply to every ART clinic?
Not to every cycle. Under 21 CFR 1271.90(a), no determination is required for autologous use or for reproductive cells or tissue donated by a sexually intimate partner of the recipient for reproductive use. Donated eggs, sperm and embryos fall under 1271.45, with narrower rules for some cryopreserved embryos in 1271.90(a)(4).