Since 2016, at least 1.1 million device-related injuries and malfunctions have been entered into the FDA's internal reporting system rather than the public-facing Manufacturer and User Facility Device Experience database, according to a Kaiser Health News investigation.
Four things to know:
1. While deaths must still be entered into MAUDE, the "alternative summary reporting" database has included injury and malfunction reports for about 100 medical devices.
2. FDA spokeswoman Deborah Kotz confirmed to KHN that the "registry exemption" was created without any public notice or regulations. "Any device manufacturer can request an exemption from its reporting requirements," she said in an email to KHN.
3. Under the exemption, device makers can summarize what they learn from registries that tend to be held by specialty medical societies and track the use of a device, according to Ms. Kotz.
4. In 2018, the FDA finalized regulations for another summary reporting program. Under the newest system, manufacturers do not have to seek an exemption or notify the FDA to file a public summary report in MAUDE.