FDA launches new device guidance website

November 27, 2012 by MassDevice staff

FDA issues guidance on its updated website as the new user Medical Device User Fee and Modernization Act takes effect.

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The FDA launched a new medical device guidance website, aiming to streamline the way the agency publishes and solicits comments on guidance documents developed by the Center for Devices & Radiological Health.

The new site includes a docket for comments where stakeholders can offer suggestions, propose draft language and comment on the priority of topics for guidance during 2013.

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The FDA's Department for Health & Human Service intends to "help get safe and effective medical devices to market more quickly" under the latest generation of the Medical Device User Fee & Modernization Act.

The new MDUFMA agreements require the FDA to publish a list of prioritized medical device guidance documents that the agency plans to publish over the next year, according to the notice.

"FDA anticipates that feedback from stakeholders, including draft language for guidance documents, will allow CDRH to better prioritize and more efficiently draft guidance that will be useful to industry and other stakeholders," the agency wrote.

FDA also plans to update its website in a timely manner to reflect the agency's review of previously published guidance documents, including policy, regulatory issues, and notation of the documents that are under review by the agency, the FDA noted.

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