Yes. FDA accepts foreign test reports in a 510(k), because what counts is the standard and version tested to, the completeness of the report and how the study was run, not where the lab is. Reports must be in English or translated, and biocompatibility studies need complete reports and a statement on Good Laboratory Practice.
Key takeaways
- FDA's standards guidance lets you base a declaration of conformity on testing by any third-party lab. You give the lab's name, address and accreditations.
- FDA recognizes specific versions of each standard. A report to an outgoing version is accepted only until the transition period in FDA's database ends.
- For biocompatibility, FDA recommends complete test reports and a statement that the studies followed 21 CFR Part 58. FDA notes it does not recognize ISO/IEC 17025 for this purpose.
- We counted FDA's ASCA-accredited labs on October 12, 2026: 98 labs, 42 of them outside the US. China had 12, Japan 7, Taiwan 5 and South Korea 2. India, Malaysia and Turkey had none.
- FDA's Refuse to Accept checklist asks for all content in English, including translations of test reports. A missing item on that checklist can put a 510(k) on hold at intake.
Does FDA accept test reports from labs outside the US?
Yes. No FDA rule limits 510(k) testing to US labs. FDA's guidance on consensus standards says a declaration of conformity can rest on testing done in-house or by a third party, such as a testing laboratory or certification body [1]. FDA's guidance on bench test reports also covers testing performed by the manufacturer or a third-party test lab, with no restriction on location [2].
What FDA asks is that you identify who did the work. If a third party did the testing, give the name and address of each lab or certification body involved, and reference their accreditations [1]. FDA may request the data behind any declaration of conformity at any time [1].
So the real question is not "Is this lab American?" It is "Does this report meet what FDA expects?" The rest of this article covers what that means.
What makes a foreign test report acceptable to FDA?
Four things, all set out in FDA guidance:
- The FDA-recognized version of the standard. FDA recognizes specific versions of a standard, and the recognized version may not be the newest [1]. When FDA recognizes a new version, its database sets a transition period. After it ends, FDA no longer accepts declarations of conformity to the outgoing version [1]. Check each standard in FDA's Recognized Consensus Standards database [8].
- A complete report. A complete test report states the test, its objective, the test method in enough detail to interpret it, the test samples, the pass or fail criteria and the results [2]. If the standard offers choices, explain the ones you made. Report any deviations from the standard [2].
- Representative samples. FDA says test samples should generally represent the final, finished device, after all manufacturing steps, including sterilization, conditioning and simulated transport. If they did not, say so and justify it [2].
- English. FDA's Refuse to Accept checklist asks whether all content supporting the 510(k) is in English, including translations of test reports and literature [3].
Know which standards apply first. Special controls and device-specific guidance often name the tests FDA expects. Complizen's Device Classification tool returns your product code with every applicable special control and the FDA guidance for your device type, so you can compare them with the reports you already hold.
How much of the report do you submit?
It depends on what the standard contains. FDA's standards guidance sets out when a declaration of conformity is enough on its own, and when you should add supporting documents [1]:
| What the recognized standard includes | Complete test report? | Supporting documentation? |
|---|---|---|
| Design requirements only | No | No |
| Test methods and acceptance criteria | No | No |
| Test methods, but no acceptance criteria | No | Yes: the criteria you used and summary results |
| Acceptance criteria, but no test methods | No | Yes |
| Neither test methods nor acceptance criteria | Yes | Yes |
For performance testing in general, FDA's acceptance checklist asks for summaries of the non-clinical studies and full test reports [3]. Our guide to consensus standards and declarations of conformity explains how to write one.
Standards also have limits. FDA notes that a device may raise issues no standard covers, and that a declaration of conformity satisfies only part of a 510(k) [1].
What extra applies to biocompatibility and animal studies?
More documentation. FDA's biocompatibility guidance, issued September 8, 2023, recommends complete test reports for all biocompatibility tests, because the ISO 10993 standards offer several methods and sometimes no acceptance criteria [4]. The exceptions are testing under FDA's ASCA program, where an ASCA summary test report may be enough, and standards where a declaration of conformity alone is appropriate [4].
Good Laboratory Practice matters more than lab accreditation. FDA says in vitro and in vivo biological safety tests should be conducted under recognized Good Laboratory Practice (GLP) regulations [4]. Include a statement that the nonclinical laboratory studies followed 21 CFR Part 58 [4, 5]. In a footnote, FDA states that it does not recognize ISO/IEC 17025, the general standard for lab competence [4]. So a national accreditation to ISO/IEC 17025 does not replace a GLP statement for these studies.
If a study did not follow GLP, for example historical data, FDA recommends explaining why and describing every deviation, so FDA can reconstruct the study [4]. Our biocompatibility guide covers the testing itself.
What is ASCA, and which labs outside the US are accredited?
ASCA, the Accreditation Scheme for Conformity Assessment, is FDA's voluntary program for accredited testing labs. FDA grants ASCA Accreditation to labs assessed against ISO/IEC 17025:2017 plus FDA's own ASCA specifications [6]. When a 510(k) includes a declaration of conformity with an ASCA summary test report, FDA says it does not intend to ask for more information about the test methods [6].
ASCA covers two groups of standards only: basic safety and essential performance of medical electrical equipment, and biocompatibility [6]. For other standards, use the normal route [6]. FDA charges manufacturers no extra fee to use it [6].
We counted the labs in FDA's ASCA database on October 12, 2026 [7]:
| Lab country | ASCA-accredited labs |
|---|---|
| United States | 56 |
| China | 12 |
| Japan | 7 |
| Italy | 5 |
| Taiwan | 5 |
| Israel | 3 |
| Canada, South Korea, United Kingdom | 2 each |
| Finland, Poland, Spain, Sweden | 1 each |
| India, Malaysia, Turkey | 0 |
Of the 98 labs, 93 are accredited for basic safety and essential performance, and 5 for biocompatibility [7].
FDA has withdrawn some accreditations. On September 18, 2025, FDA said it had withdrawn ASCA Accreditation from certain labs after audits. In some cases it had concerns about the integrity of data those labs submitted. ASCA summary test reports from those labs are no longer accepted [6]. Check a lab's current status before you rely on its reports.
Few 2025 510(k)s mention it. Only 6 of the 3,070 public 510(k) summaries for devices cleared in 2025 mentioned ASCA [9]. ASCA is optional, and a lab without it can still produce reports FDA accepts.
Can you reuse test reports from CE marking or a national registration?
Often, yes, if the reports meet the points above. If your CE or national reports used FDA-recognized standards, they may carry over. Check each one against the version, completeness, sample and GLP points in this article rather than assuming it does.
Complizen's free Gap Assessment reviews the test reports you already have, including any prepared for CE marking or a domestic submission, and names what is missing for a 510(k).
For what else carries over from your home approval, see our guides for CE marking, South Korea's MFDS, Japan's PMDA, Taiwan's TFDA, Malaysia's MDA and India's CDSCO.
Clinical data follows separate rules. Data from a clinical investigation outside the US is accepted under 21 CFR 812.28, which requires good clinical practice and supporting information [10].
What gaps does FDA most often find in foreign test reports?
These six follow directly from FDA's guidance, and each can stop or slow a 510(k):
| Gap | What FDA's guidance says |
|---|---|
| Tested to an outgoing version of a standard | FDA accepts declarations to the old version only until the transition period ends [1] |
| Summary or certificate where a full report is needed | FDA's checklist asks for full test reports for performance data [3] |
| No GLP statement for biocompatibility or animal studies | FDA recommends a statement of compliance with 21 CFR Part 58, or an explanation of deviations [4] |
| Report not in English | All supporting content should be in English, including translations [3] |
| Choices and deviations not explained | Explain choices a standard allows, and report deviations [2] |
| Samples not the final device | Samples should generally reflect all manufacturing steps, including sterilization [2] |
Finding these before you submit matters for timing. If FDA cannot accept your 510(k), its review clock does not start until the 510(k) is accepted [3]. Our guide to 510(k) review times by country shows how much that waiting time differs between applicant countries.
Frequently asked questions
Does FDA accept foreign test reports?
Yes. FDA accepts foreign test reports in a 510(k) when they meet its expectations: the FDA-recognized version of the standard, a complete report where needed, representative samples, English or translated text, and GLP compliance for biocompatibility studies. FDA has no rule requiring US labs.
Do test labs need to be FDA-approved?
No. FDA does not approve testing labs for 510(k)s. You give the name, address and accreditations of each lab involved. FDA runs a voluntary program, ASCA, that accredits labs for some standards, but a lab without ASCA accreditation can still produce acceptable reports.
Is ISO/IEC 17025 accreditation enough for FDA?
Not for biocompatibility. FDA says biological safety tests should follow Good Laboratory Practice under 21 CFR Part 58, and notes that it does not recognize ISO/IEC 17025 for that purpose. ISO/IEC 17025 is, however, part of how labs earn FDA's ASCA accreditation.
What is an ASCA summary test report?
It is a report format from a lab with FDA's ASCA accreditation. When you include one with a declaration of conformity, FDA says it does not intend to request more information about the test methods. ASCA covers only basic safety and essential performance standards and biocompatibility standards.
How many ASCA-accredited labs are outside the US?
On October 12, 2026, FDA's ASCA database listed 98 accredited labs, 42 of them outside the US. China had 12, Japan 7, Italy and Taiwan 5 each, Israel 3, and South Korea, Canada and the UK 2 each. India, Malaysia and Turkey had none.
Do test reports have to be in English?
Yes. FDA's Refuse to Accept checklist asks whether all content used to support the 510(k) is in English, including translations of test reports and literature. If FDA cannot accept the 510(k), its review days do not start until you send a complete response.
Can I use my CE marking test reports for a 510(k)?
Often, if they meet FDA's expectations. Check that each standard is the FDA-recognized version, that full reports are available where needed, that samples were the final device, and that biocompatibility studies have a GLP statement. Translate anything not in English.
What happens if my test standard version is outdated?
FDA sets a transition period when it recognizes a newer version of a standard. After the transition period ends, FDA no longer accepts declarations of conformity to the old version. FDA encourages talking to it early if a standard changes during development.
Do I submit the full test report or just a declaration of conformity?
It depends on the standard. A declaration alone may be enough when the recognized standard includes both test methods and acceptance criteria. When it lacks either, add supporting documents. For biocompatibility, FDA recommends complete test reports for all tests, unless an ASCA summary report is enough.
Does FDA ever check foreign test labs?
FDA may request the data behind any declaration of conformity at any time. For ASCA labs, FDA runs audits. In September 2025, it withdrew ASCA Accreditation from certain labs, partly over concerns about data integrity, and stopped accepting their ASCA summary test reports.
Can a test on a prototype support a 510(k)?
Sometimes. FDA says test samples should generally represent the final, finished device after all manufacturing processes, including sterilization and simulated transport. If you tested something else, state this in the report and justify why the results still apply to the device you will sell.
Does this apply to clinical data from outside the US?
No, clinical data has its own rules. FDA accepts data from clinical investigations outside the US under 21 CFR 812.28 if the study followed good clinical practice. You must also provide the required supporting information, such as investigators, sites and protocol details.
References
- FDA. Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. Final guidance, September 14, 2018.
- FDA. Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions. Final guidance, December 20, 2019.
- FDA. Refuse to Accept Policy for 510(k)s. Final guidance, April 21, 2022.
- FDA. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Final guidance, September 8, 2023.
- eCFR. 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. Up to date as of October 7, 2026.
- FDA. Accreditation Scheme for Conformity Assessment (ASCA). Content current as of January 28, 2026.
- FDA. ASCA-Accredited Testing Laboratories database. Accessed October 12, 2026.
- FDA. Recognized Consensus Standards database. Accessed October 12, 2026.
- FDA. 510(k) Premarket Notification database, 510(k) summaries for 2025 clearances. Accessed October 9, 2026.
- eCFR. 21 CFR 812.28, Acceptance of data from clinical investigations conducted outside the United States. Up to date as of October 7, 2026.