Regulating innovation: FDA's medical device approval process : hearing before the Subcommittee on Investigations and Oversight of the Committee on Science, Space, and Technology, U.S. House of Representatives, One Hundred Third Congress, first session, September 17, 1993, Volume 4
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90 days Accept Policy additional agency Alpert backlog CDRH Center for Devices Chairman checklist clinical clinical study design cost criteria cycle decision device approval process Device Evaluation Devices and Radiological Director Division of Small DON JOHNSON DSMA ensure FDA review FDA's File Policy going guidance documents Hayes HIMA HIMA's hypodermic needles IDE applications implemented innovation Investigational Device Exemptions Investigations and Oversight issues John Linder Johnson & Johnson Kohl Linder medical device medical waste Mooibroek Nathan Deal needlestick needlestick injuries O'Holla Office of Device Okay percent PMA Supplements problems product approval product review public health questions Radiological Health received Refuse to Accept Refuse to File regulations requests requirements review process review queue reviewing Division scientific review Small Manufacturers sponsor staff startup companies Stigi submitted substantially equivalent syringe Thank user fees