Senate User Fee Bill Sets Up New Path To Reclassify Device Accessories

The Senate user fee package unveiled Monday (May 8) sets up a process for device makers to request FDA reclassify based on their intended use accessories that were previously linked to the higher-risk classification of their parent device. Device makers would be required to submit an application with supporting information to FDA, which would have 60 days to weigh in, but the bill doesn't lay out the standard the agency would use in its decision, an industry attorney tells Inside...