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additive in medical


the Middle East and South America, in addition to the United States. Oxford was due to break into the Japanese market in January.


“Essentially, say, ‘My device has the same intended use and it shares the same technical characteristics


as this previous device.’ ”


“We do them every week now,” he said of the devices. Oxford obtained clearance to market the device within the


FDA’s self-imposed time frame of 90 days, he said, because the government agency already had extensive data on the biocompatibility and purity of the proprietary raw material, OsteoFab; all processes were developed internally; and the company controls the entire supply chain. “In our cranial device, where things got complicated is that we do patient-specific devices,” said DeFelice. He ex- plained that the FDA already had addressed the patient-spe- cific issue with metal skull prostheses, so the agency knew what to look for and that moved the process along. “What it basically means at the end of the day is the FDA will evaluate your ability to design and produce your prod- uct,” he said. Oxford had already done about 30 skull prostheses outside of the United States before submitting its request for clearance to the FDA. His company recently submitted for approval a mid-face implant (for the bone around the eye and cheek) A device for spine fusion is in the works. “So, it’s a very broad platform [for OsteoFab],” he said.


Going Independent While DeFelice has in-house advisers to help with the


regulatory process, not everyone is so fortunate. For them, there are independent consultants, some of whom previously worked for the FDA.


One such consultant is Dennis Moore, of The FDA Group


(Westborough, MA), who has 30 years’ experience with the government agency, both as an employee and an adviser. “One thing that people should keep in mind is that it’s not a very well-defined process,” he said. “Nothing is absolute. I’ve seen exceptions to every rule.”


That said, Moore offers his three-step process for FDA 510(k) clearance (for Class II devices) or pre-market approval (for Class III devices).


His step No. 1 is to determine what already-approved


item—a predicate device—most resembles your bright idea. “And that’s not always an easy task,” Moore said. The goal is to closely define what your device is by its intended use: “A toothpick becomes a device when you say it removes plaque,” Moore explained. “A cotton swab may be a cosmetic product until it’s used to clean a wound bed. “The whole game is to ramp down your claim so you can get clearance.” Attorney James Lawrence, of the Coats & Bennett law firm in the Research Triangle Park area of North Carolina, said of the predicate device process: “Essentially, say, ‘Here’s my device, and here’s a predicate device. My device has the same intended use and it shares the same technical charac- teristics as this previous device.’ ” Lawrence interned at the FDA. He offers an insider tip about the predicate device process. “FDA reviewers are wary of ‘predicate creep,’ where sub- missions veer further and further away from something that’s been approved,” Lawrence said. Moore recommends making a blind call to the FDA’s Divi- sion of Small Manufacturers Assistance line (1-800-638-2041) and saying, “We’ve got this widget, what do you think?” Or, for a few thousand dollars, you can send in your device and the FDA will tell you where its staff thinks it fits. The process takes 30–60 days, Moore said. It can pay off to match your invention to a predicate de-


vice carefully, he warns. “If approached correctly and you can tone down the claim enough you can sometimes avoid a clinical trial,” said Moore. Clinical trials typically require a minimum of 50 patients, and each patient’s costs can tally $10,000 or more, he said. Some makers get a toehold in foreign markets, where


regulatory hurdles are lower, before trying to get their device approved in the US. This offers the advantage of having pa- tient usage data that can be included in an FDA submission. “In some cases you can leverage that to a degree,” said


Moore. Lawrence is more optimistic: “You can rely on data from trials that were conducted outside the US,” he said. “You just have to make sure it complies with the laws in the country of origin.”


After figuring out what your predicate device is, Moore said the next hurdle is to strategize the steps you need


60 — Medical Manufacturing 2015


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