Additive Manufacturing
“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 explained that the FDA already had addressed the patient-specific issue with metal skull prostheses, so the agen- cy 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 product,” he said.
Oxford had already done about 30 skull prostheses outside of the United States before submitting its request for clear- ance to the FDA. DeFelice declined to go into detail regarding clinical trials.
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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.
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“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.
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“My device has the same intended use and it shares the same technical characteristics as this previous device.’ ” Lawrence, who has an undergraduate biomedical engineer- ing degree in addition to his law degree, 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.
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Moore recommends making a blind call to the FDA’s Divi- sion of Small Manufacturers Assistance line (1-800-638-2041 or 301-796-7100) and saying, “We’ve got this widget, what do you think?” Or, for a few thousand dollars, you can send in
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PRODUCTS NEW
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