Be Clear on Medical

Device Clearance Process What ASCs need to know about FDA 510(k) BY ROBERT KURTZ


hile ASCs have no role in the US Food & Drug Administra-

tion’s (FDA) pre-market notification 510(k) medical device clearance pro- cess, it is imperative that they under- stand 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 concern- ing 510(k) clearance,” she says. “Even a baseline understanding of the pro- cess can go a long way toward helping ASCs ensure they are delivering safe, appropriate care.”

Overview If a company wants to commercial- ize a medical device in the US mar- ket, it must register as a facility and list the device with the FDA, says Pamela


Anderson, quality assurance/regula- tory affairs director, legal and compli- ance, for Vizient, a group purchasing and performance improvement com- pany based in Irving, Texas. Anderson notes that most devices receive either a 510(k) clearance or a pre-market approval (PMA).

Harmer says that most class II (or “medium-risk”) devices as well as a small number of class I (“low-risk”) and class III (“high-risk”) devices require a 510(k) submission. Exam- ples of class III devices are intraocu- lar lenses, spinal pedicle screws and breast implants. Regulatory control increases from class I to class III. Most class I devices are exempt from 510(k) clearance, most class II devices require 510(k) clearance and almost all class III devices require PMA. “PMA is the FDA process of sci- entific and regulatory review used to


evaluate the safety and effectiveness of class III devices,” Anderson says. A majority of devices used in ASCs require 510(k) clearance, Harmer says. The first step a company must go through to obtain 510(k) device clearance is to make sure the prod- uct qualifies as a medical device, she says. “There is a very verbose defi- nition from the Federal Food, Drug, and Cosmetic Act (FD&C) of what a medical device is.” Go to NTdgGc to find out what qualifies a product as a medical device. If the product meets the legal def- inition of a device and the company determines its classification makes it eligible for a 510(k) review, Harmer says the next step is for the company to find a predicate device against which to compare the device. A predicate device is one that is “technologically similar and shares the same intended uses as the company’s new product,” she says. This is to show “substantial equivalence,” meaning that the new device is at least as safe and effective as the predicate.

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