While ASCs have no role in the US Food & Drug Administration’s (FDA) pre-market notification 510(k) medical device clearance process, it is imperative that they understand what the clearance does and does not include and cover, says Barbara Ann Harmer, president at MedAssist Consultants, a provider of medical and surgical consulting services based in Gainesville, Florida.
“There is often confusion concerning 510(k) clearance,” she says. “Even a baseline understanding of the process can go a long way toward helping ASCs ensure they are delivering safe, appropriate care.”