The U.S. Food and Drug Administration (FDA) is calling on medical device manufacturers to independently verify third-party-generated test results included in premarket submissions to the agency.
In a letter to industry issued Feb. 20, the FDA said that in recent years, contracted third-party testing laboratories have fabricated test data or duplicated test data used in other device submissions. , noted that they are observing an increasing number of tests that provide unreliable characterization. The letter does not identify the specific laboratories that generated the fabricated test data, but points to “a number of such facilities based in China and India.”
In these cases, the FDA states that the inclusion of false or fabricated data in a premarket application compromises the integrity of the entire premarket application. Therefore, the agency has no choice but to refuse the marketing authorization application.
FDA advises device manufacturers to work with third-party testing laboratories accredited under the Autonomous System of Conformity Assessment and Accreditation (ASCA) to reduce the possibility of fraudulent test results being provided. I am. However, the FDA also cautions that using an accredited laboratory does not completely eliminate the possibility of fraud, and that careful evaluation of third-party testing data is still strongly recommended. .
Read FDA’s letter to industry about the need to carefully review and scrutinize third-party generated data used in premarket applications.