FDA’s New Device Surveillance Expansion Faces Barriers

Based on a recent government study, the FDA has taken measures to build an active postmarket surveillance system to monitor the reliability of medical devices but has encountered two major obstacles.

Based on a Government Accountability Office (GAO) report released, the FDA intends to begin active surveillance for two different types of devices by December and to gradually extend the program over a five-year period.

It is more difficult to determine the devices people use, according to the GAO, because payers and healthcare providers utilise unique device IDs less frequently. Manufacturers utilise codes on product labels called unique devices to link a particular medical device to a particular patient.

As mandated by a 2013 FDA final regulation, device makers already employ unique device IDs. Nevertheless, according to the GAO study, the FDA is not able to require physicians to enter IDs into electronic health records or utilise them for billing purposes.

And the second difficulty is financing. According to FDA estimates, it will cost $8 million to set up and operate an active surveillance system. The department is asking Congress for an additional $3 million to pay the remaining costs of the project, and aims to dedicate $5 million of its current yearly funding to it.