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Michael Carome quoted in MedTech Dive about FDA alternative reporting program

MedTech Dive

By David Lim

“This program should never had been implemented and the data never been hidden, but we certainly welcome the fact that that data is now publicly available,” Michael Carome, director of Public Citizen’s Health Research Group, told MedTech Dive.

In the final rule issued last August instituting the Voluntary Malfunction Summary Reporting Program, FDA disagreed with comments that argued the program would limit transparency and not provide critical information about the adverse events being summarized. Public Citizen, for example, requested FDA publicly post the product classification codes for the categories of medical devices eligible for the program.



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