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EnteroMedics Inc. Message Board

  • dctrig dctrig Apr 11, 2013 2:24 PM Flag

    New FDA News Benefits EnteroMedics

    The FDA is requesting about $870 million to run the Center for Devices and Radiological Health (CDRH) in the next fiscal year, an 11% funding increase over 2012 that the agency says will speed up approvals of new technology.

    The request, part of President Barack Obama's fiscal 2014 budget proposal, tabs about $151.6 million for approvals and clearances and around $39.9 million for post-market safety. The rest is largely divided between radiation compliance enforcement, IT investments and mammography monitoring.

    The agency's budget request comes with some performance benchmarks for CDRH, aiming to review and decide on 80% of PMA applications within 180 days of filing and 93% of 510(k)s within 90 days.

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