Lexology March 12, 2025
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the Center for Devices and Radiological Health (CDRH or Center), notified device manufacturers and the public that it had “observed that an increasing number of entities that contract with device firms to conduct testing … are generating testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable.” FDA has continued to express data integrity concerns about testing labs in the intervening year and has issued warning letters to certain testing labs for violations of good laboratory practices (GLPs). CDRH officials have also confirmed that concerns about data...
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