Center for Devices and Radiological Health Annual Report, Fiscal Year 1998

摘要

We're continuing a major re-engineering effort to make our program more211u001eresponsive to our stakeholders and, on a parallel track, have made substantial 211u001eprogress in implementing the device provisions of the FDA Modernization Act 211u001e(FDAMA). One result is a growing menu of options for manufacturers in bringing 211u001enew products to market. With our resources stretched thin, we must in the future 211u001elook towards a new inspection model aimed selectively at relatively high-risk, 211u001ehigh-impact devices. We want to hear from our stakeholders about the impact our 211u001eprograms are having and how they can be improved.