Why We're Telling Clients to Stop Relying on Third-Party Test Data From China & India

If your last 510(k) depended on third-party lab data for biocompatibility or performance testing from an overseas contract lab, it's worth pulling that file and asking yourself: can you defend every number in it? The FDA is now rejecting entire datasets from specific third-party testing facilities, and the sponsors who used them are experiencing not only delay but no certainty of a timeline. At RookQS, we have seen this put submissions into regulatory purgatory. And unfortunately, even though these labs aren’t specifically named in FDA’s press release, they were still flagged.

Medical device innovators often treat third-party test results as a plug and play item that can be bought from the lowest bidder but that assumption can be costly as FDA takes the actions it feels are necessary to prevent fraudulent data.

What did the FDA do about China and India lab data?

The FDA has taken three clear steps over the years.

In February 2024, CDRH issued a notification titled "Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions," reminding manufacturers to scrutinize third-party-generated data. The agency stated plainly that it had identified an increase in submissions containing unreliable data from third-party test labs, "including from numerous such facilities based in China and India." That data was described as “fabricated, duplicated from other submissions, or otherwise unreliable.”

In September 2024, the FDA issued warning letters to two Chinese nonclinical testing labs, Mid-Link Technology Testing Co. in Tianjin and the Sanitation & Environment Technology Institute of Soochow University (dba SDWH) in Suzhou. Inspections found what the agency called pervasive failures in data management, quality assurance, staff training, and oversight, plus animal care violations. The core problem was a failure to accurately record and verify key research data.

In May 2025, the FDA escalated again with General Correspondence Letters to both firms. The agency determined that each had, in several instances, copied results from another study or created falsified or invalid data. The consequence is the part that should get your attention: until the firms adequately address these issues, all study data from all studies conducted at these facilities will be rejected. You read that right: FDA is not just applying additional scrutiny to the data during reviews but outright rejecting any and all data from these test labs.

Why FDA data rejection reaches your 510(k) submission

Two named labs may sound narrow, but the exposure is wider than that.

The February 2024 notification named China and India as regions of concern, not just two specific firms. Although FDA states its rejection applies to the specific facilities, it’s clear the two regions are under heightened scrutiny all together. 

The responsibility is with you as the device manufacturer, rather than the lab. The FDA has been consistent that using a third party does not relieve the sponsor of accountability for the accuracy of data in a submission. The agency expects device firms to identify results that are improbable or impossible on their face, or inconsistent with what is known about the device. Unfortunately, "the lab gave us these numbers" is not an accepted defense.

How to reduce third-party lab data risk before you submit

Given the current pattern, Rook is advising clients to avoid relying on third-party test data generated in China and India for premarket submissions, and to route new biocompatibility, performance, and safety testing to labs where data integrity can be independently verified. This is a deliberate risk-reduction decision that looks like this:

1. Inventory your active and recent submissions. Identify every study sourced from a third-party lab, note the facility and location, and cross-check named firms against the FDA's Notifications on Data Integrity page.

2. Treat the FDA list as a minimum requirement. For any lab in a flagged region, ask for the underlying records, not just the summary report: raw data, equipment logs, animal identification and care records, and analyst qualifications.

3. Build a real qualification step into supplier oversight. A third-party lab is a supplier, and it belongs in your supplier evaluation process with the same rigor you apply to a component manufacturer. Documentation of that qualification is what an FDA reviewer will want to see.

4. Verify before you submit, not after a deficiency letter. Sanity-check results against known device characteristics and comparable predicates. Data that looks too clean, or suspiciously similar to another product's file, is worth a second look before it gets to the agency.

5. When in doubt, re-test with a lab you can trust. A re-test certainly has a cost, but a rejected submission and a lost review cycle usually cost more in both time and momentum.
   

Key takeaway: verify third-party lab data before you submit

The question to bring to your next team meeting is: for every third-party study in our pipeline, can we independently verify the data, and do we know exactly where it was generated? If the answer is no for any study tied to a flagged region, that is where to start.

Data integrity is now a gating item for market access, and the burden of proof sits with the sponsor. Getting ahead of it protects your timeline far more than it slows it down.

Get a second set of eyes on your third-party data

Rook works as an embedded part of your quality and regulatory team. If you want to know where your submissions are exposed, we'll review the third-party studies in your pipeline, flag the data most likely to draw an FDA question, and give you a corrected plan to close the gaps before you file.

Book a free discovery call with our team. You'll walk away knowing exactly which studies you can defend and which ones need a second look, before the FDA does it for you.