This Week at FDA: A glut of guidances

The Center for Devices and Radiological Health (CDRH) proposed three new guidances this week aimed at modernizing its premarket notification program, more commonly known as the 510(k) pathway. The guidances propose best practices when selecting a predicate device in a 510(k) submission, situations when clinical data may be necessary, and the kinds of evidence the agency expects to see for 510(k) implanted devices.