The FDA will end a program that allowed devicemakers to conceal reports of device-related harm and malfunctions from the public and physicians, according to Kaiser Health News.
Four things to know:
1. Under the program, known as "alternative summary reporting," medical device manufacturers could apply for an FDA exemption to prevent specific incidents from going on the public FDA database. Kaiser Health News found at least 1.1 million device incidents had been reported to the alternate FDA database since 2016.
2. The FDA will open records from the database to the public in a few weeks.
3. The program was created in 1997 to collect data for more efficient internal review of well-known risks. It was updated in 2017 to promote greater public transparency. Only low-risk products were eligible for the alternative reporting method.
4. Now that the FDA is halting the program, devicemakers will be required to file individual reports documenting each case of device-related patient harm.
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