The United States Food and Drug Administration (FDA) has launched a new device guidance website as the Modernization Act and the Medical Device User fee come into play. The new website by the FDA aims to streamline the agency’s publishing process. In addition, the FDA will use the new website to solicit comments on regulatory guidance documents that were created by the U.S. Center for Devices & Radiological Health.
The site includes a variety of new features to enhance two-way communication between the FDA, manufacturers and the public. With a new docket for comments, stakeholders in a decision will be able to provide their own suggestions. In addition, stakeholders will be able to propose prioritization of guidance topics and new draft language.
According to the notice, the FDA will use its Department for Health & Human Services to get effective and safe medical devices to the public market quickly and easily. This will be made possible under the U.S. Medical Device User Fee & Modernization Act. The new agreements under this act will require the FDA to publish documents of medical device guidance for the upcoming year.
In its prepared notice, the FDA stated that it “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including draft language for guidance documents, will allow CDRH to better prioritize and more efficiently draft guidance that will be useful to industry and other stakeholders.”
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