FDA Updates Two 510(k) Marketing Guidances

Makers of ultrasound equipment and intravascular (IV) administration sets and accessories have updated guidance to direct them through the FDA’s marketing process. A new guidance tells ultrasound manufacturers they no longer need to submit a 510(k) Special Report if they maintain acoustic output measurements and labeling records for their devices in their device history file. In a second guidance, the FDA advises IV manufacturers to submit an Abbreviated 510(k) to demonstrate substantial equivalence for a new device. Firms considering modifications to devices they’ve already cleared should submit a Special 510(k). However, if the company prefers, it may submit a traditional 510(k) in either case.

SOURCE: FDANEWS