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CDRH Seeks Comments on 510(k) Device Process

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration's Center for Devices and Radiological Health is reaching out to industry and the public for input on its plans to change the process for handling 510(k) submissions by collecting public comments and holding a public meeting in March.

As GenomeWeb Daily News reported in January, CDRH has issued a 25-point plan aimed at streamlining the review process, clarifying when clinical data should be submitted, and establishing a council of FDA experts to assist applicants in making decisions.

CDRH Director Jeffrey Shuren said at the time that the changes 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."

These steps are being considered in order to "strengthen" the review process and to "improve the predictability, consistency, and transparency of its decision-making," CDRH said in a Federal Register posting this week.

"These actions will not only improve the safety of medical devices but also increase the ability of innovating companies to attract investors, estimate costs, and more quickly bring products to market," according to CDRH.

The Center plans to hold is public meeting on March 15 in Silver Spring, Md., at FDA's White Oak Campus.

CDRH is seeking comments on its report in general, as well as in certain areas, such as the eligibility criteria for the new programs; how CDRH should determine what types of technologies will be included in some of these new innovation initiatives; how time frames for the program should work; what criteria should be used for clinical test center certification; how candidates for inter-agency or public-private partnerships will be defined; and other actions CDRH should take to facilitate the development, assessment, and regulatory review of innovative medical devices.

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