The FDA's Center for Devices and Radiological Health is adding employees and directing user-fee funds as it attempts to finish its reclassification of medical devices. The agency expects the reclassification to address concerns that 25 types of high-risk or Class III devices, including intra-aortic balloon systems and implantable pacemaker pulse generators, continue to reach the market without being subject to sufficient review via the 510(k) program.

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