FDA Tips From Unreleased Guidance Help Dx Company Get 510(k)

As the FDA faces continuing criticism about unpredictable 510(k) review standards, one devicemaker says the agency helped it win clearance by giving it a heads up on a pending guidance. bioMérieux won clearance late last month for its automated molecular test for methicillin-resistant Staphylococcus aureus (MRSA), the NucliSENS Easy Q MRSA. But the test might not have reached the U.S. market if CDRH staffers had not teamed up with the company to share information from a guidance that was still months away from release, Steve Shumoski, marketing manager for molecular diagnostics at bioMérieux said.
Devices & Diagnostics Letter