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FDA releases streamlined de novo proposals

by Brendon Nafziger, DOTmed News Associate Editor | October 03, 2011
The Food and Drug Administration released, Monday, long-awaited proposed revisions for the de novo medical device clearance process, which the agency said could make product reviews up to 90 days faster.

The de novo process is for low to moderate-risk medical devices which aren't eligible for 510(k) clearance because they aren't similar to a product currently on the market, as required under FDA's 510(k) rules. Currently, only after a product has been rejected for 510(k) clearance can a company then file a de novo petition for it. This can then result in delays or scuttling of the submission if the agency needs more information to see if it's de novo-worthy.

The FDA said because of such "process inefficiencies" the pathway, developed out of a 1997 law, has been underused.
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"FDA believes that the process could be improved and greater clarity could be provided regarding suitability and data needed so that the de novo process may be a more viable pathway for novel low to moderate risk devices," the agency said in the draft guidance.

In the new guidance documents, the FDA calls for providing a new step, called a pre de novo submission, or PDS, which allows companies that think their product is completely novel, but low risk, to get FDA's feedback to make sure the application is complete, and to prevent snags later in the review. It also allows companies to file a joint 510(k) submission to streamline the whole device clearance process. However, under the new proposals, companies could still file their applications the old way.

"Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "Creating a pathway for a concurrent 510(k) and de novo petition streamlines the de novo program, helping speed safe and effective devices to patients."

The Advanced Medical Technology Association, or AdvaMed, a medical device manufacturer's lobby, said it was reviewing the guidance, but that it supported changes to improve the de novo process, which it said "takes too long."

“Medical technology manufacturers are particularly frustrated with the current process’ requirement that a 510(k) must be submitted and receive a 'not substantially equivalent' (NSE) determination before a de novo classification can be requested," Janet Trunzo, executive vice president for technology and regulatory affairs, said in a statement. "FDA’s proposed option for a 'one-step' process in addition to the current two-step process – with the manufacturer having the choice of pursuing either the one-step -or two-step process –- may be a good start to streamlining the de novo process."

The agency is accepting comments on the guidance, one of 25 "action" items it plans to tackle to make the medical device review process safer and more efficient, for the next 90 days.

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