FDA warns medical device makers about rise in fabricated data

An increasing number of medical device companies are submitting fabricated and unreliable data, the Food and Drug Administration noted Tuesday morning. The data comes from third-party labs hired by device firms to test the quality of their products.

Triple-check your data or we’ll reject your device, the FDA warned.

The goal of third-party testing is to ensure a device meets the FDA’s standards in a range of areas, including biocompatibility, sterility, and mechanical performance. The agency wrote that it has noticed an uptick in false data submissions in recent years, particularly from facilities based in China and India. In some cases, the facilities will send data copied from previous device submissions.

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