The US Food and Drug Administration (FDA) is warning medtech sponsors and manufacturers to double-check the work of third-party testing laboratories before their data is submitted in premarket submissions. The agency is concerned that some labs are faking data and singled out entities from China and India.
On 20 February, FDA published a letter to the medtech industry stating that companies must ensure that third-party laboratories tasked with conducting clinical trials and gathering data for premarket submissions are reliable.
“In recent years, the FDA has observed that an increasing number of entities that contract with device firms to conduct testing on medical devices (‘third-party test labs’) are generating testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable,” said the agency. “When such data are submitted to the FDA, the agency is unable to rely on them to grant marketing authorization and it calls into question the data integrity of the entire file.”…
