COVER: Be Clear on Medical Device Clearance Process

Be Clear on Medical Device Clearance Process

What ASCs need to know about FDA 510(k)

BY ROBERT KURTZ   |  NOVEMBER-DECEMBER 2017

Be Clear on Medical Device Clearance Process

Even a baseline understanding of the 510(k) process can go a long way toward helping ASCs ensure they are delivering safe, appropriate care.

COVER STORY

Be Clear on Medical Device Clearance Process

What ASCs need to know about FDA 510(k)

BY ROBERT KURTZ   |  NOVEMBER-DECEMBER 2017

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.”

 

To read this article, you have to be a member of ASCA or subscribe to ASC Focus magazine.

Already a member or subscriber? Log in.

To become a member, click here. To subscribe to ASC Focus, click here.