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UPDATE: FDA Plans Streamlining 510(k) Process in 2011

The story has been updated to include additional comments.

By Matt Jones

NEW YORK (GenomeWeb News) – The US Food and Drug Administration on Wednesday unveiled plan for ways it will try to improve the path to market for medical devices over the coming year.

The 25-point action plan for 2011 is aimed at streamlining the review process, clarifying when clinical data should be submitted, and establishing a new Center Science Council of senior FDA experts to aid in making decisions.

These steps to clear the path for 510(k) submissions will result in "a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly," explained Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), in a statement.

The process to change the 510(k) submission and premarket notification process began in 2009, when CDRH started internal working groups to address concerns that this process was "unpredictable, inconsistent and opaque," according to an FDA report on the proposed changes.

FDA also worked with the Institute of Medicine and it has sought public input to inform its working groups as it developed internal reports that eventually led to a large set of 55 recommendations, which have been narrowed down to this 25-step plan for 2011.

Over the coming year, FDA plans to release draft guidances for a number of its recommendations, to continue to hold public meetings covering some potential changes, and to post pertinent changes in rules to its website.

These efforts will include publication of draft guidance proposals for implementing a number of changes, including: changes aimed at improving the quality and performance of clinical trials; efforts to clarify the process for appealing CDRH decisions; steps to streamline the de novo classification process; steps to enhance clarity regarding when clinical data should be submitted; criteria for identifying safety and effectiveness issues; and the characteristics that should be included in the concept of "intended use."

The agency also will take steps to establish a Center Science Council, assess its staffing needs and training new staff, and develop a network of external experts to appropriate and use external scientific expertise.

Other programs will aim to develop FDA policies on how much additional information about regulated products may be available; developing an on-line labeling repository; consolidating the concepts of "intended use" and "indication for use’ into the term "intended use;" and seeking the authority to require post-market surveillance studies as a condition of clearance for certain devices, among others.

John Babitt, Ernst & Young’s Medtech Leader for the Americas told GenomeWeb Daily News that the "biggest impact is what did not happen," referring to an earlier proposal from the Center for Devices and Radiological Health to create a new type of class II category for medical devices called the IIb category.

There has been "quite a bit of concern that a lot of devices that are very incremental and truly do qualify for the spirit of what the 510(k) is would be bracketed" into the new IIb category, which could result in the need for clinical trials for more devices, Babitt explained.

He said that FDA essentially "punted"" on the IIb category issue for the time being, and that diagnostics developers and investors probably will be the beneficiaries of the decision.

"Investors are pretty good at determining which devices are kind of a true 510(k), which ones are a (510)k with [requirement for clinical trials], and which ones are going to fall into a pre-market approval device category," Babitt said. "From an investors perspective this keeps the status quo."

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