The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise found to be invalid.” The press release can be found here. These letters represent the most recent development in a series of communications between the FDA and the companies regarding generation of study data.
The China-based companies, Mid-Link Testing Company Ltd. and Sanitation & Environmental Technology Institute of Soochow University Ltd., provide testing and validation data services for premarket device submissions. The FDA will be rejecting any data from the two companies generated for use in premarket device submissions.
Among other things, the General Correspondence Letters (found here and here) conclude that the companies “created results that were copied from the results of another study” or reported results that were “highly improbable.” Additionally, the letters conclude that neither laboratory adequately addressed the FDA’s concerns as laid out in previous letters.
As we discussed in a previous blog post, the FDA has had concerns around use of third-party data for submissions. The FDA noted recent increases in unreliable data in submissions and stressed that device companies are responsible for evaluating and verifying all testing results submitted to the FDA.
We have also previously discussed that the Center for Devices and Radiological Health (CDRH) released a dataset to assist medical device firms assess capabilities of third-party analytical chemistry labs. Additionally, the FDA maintains a list of testing laboratories accredited under the Accreditation Scheme for Conformity Assessment (ASCA). ASCA is intended to accredit testing laboratories to perform premarket testing for medical devices. At the time of posting, the ASCA-accredited lab list includes 113 different testing laboratories.
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