For AirXpanders, a switch from 510(k) to de novo was no big deal

Scott Dodson didn’t worry when the FDA requested a call. Dodson is CEO of AirXpanders, a Palo Alto, Calif.-based company that had made a 510(k) submission for its AeroForm tissue expander, a device designed for post-mastectomy breast reconstructions that uses a gradual patient-controlled release of compressed gas to expand and stretch the skin/underlying muscle before a permanent breast implant. With that in mind, the FDA wanting to speak with AirXpanders’ executives was initially seen as a positive, Dodson said. However, regulators explained over the phone, then by fax, that they saw AeroForm more appropriately as a de novo submission, a designation for low- to moderate-risk devices that don’t have a “substantially equivalent predecessor” device already on the market. Translated: The FDA’s recommendations meant some fast changes were in order. Dodson and his team quickly decided to adapt to the new requirements, despite the longer time frame. A 510(k) submission has a 90-day clock, for example, while de novo applications have a 120 day clock (both of which can stop and then restart as regulators seek more information or have questions). Dodson said reworking the application to a de novo format took about 2½ weeks to complete and then resubmit. The de novo route has clear advantages, he added, a process he described as being somewhat more free flowing than the 510(k). “During the de novo process, from what the FDA explains to us, if...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Women's Health Breast Cancer MassDevice Q&A Source Type: news