When a new medical device hits the market, there’s typically still some uncertainty about whether it works.
Device makers generally do not have to submit as much, or as rigorous, clinical data to the Food and Drug Administration as their biotech counterparts. Once FDA regulators decide a device is safe and effective, companies and researchers then attempt to track how the device performs in the real world.
But tracking devices is tricky. The FDA requires that manufacturers tag each of its devices with a unique code, or identification number, but the Centers for Medicare and Medicaid Services and insurance companies do not require that physicians mark these numbers on reimbursement forms. This makes it incredibly difficult for researchers to observe device performance trends in claims data, and for hospitals to reach out to patients when specific devices are recalled. Because of this, comprehensive medical device databases are rare.
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