Food and Drug Enforcement Standards for Medical Devices: Joint Hearing Before the Subcommittee on Human Resources and Intergovernmental Relations and the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fourth Congress, First Session, September 14, 1995
U.S. Government Printing Office, Jan 1, 1997 - Administrative procedure - 231 pages
What people are saying - Write a review
We haven't found any reviews in the usual places.
Other editions - View all
Administrative Procedures Act agency agency's American angioplasty announced application approval process beneﬁt BRINKER CDRH Center for Devices Certiﬁcate Chairman Christopher Shays Citizens Petition classiﬁcation clinical trials communications companies compliance Congress DCLD delay device approval Dockets and Management Drug Administration endocardial leads ensure Europe European Evaluation example FDA approval FDA's FDA’s Federal ﬁrm ﬁrst Food and Drug guidance documents guidelines hearing heart Hudson Institute human costs Indiana Medical Device informal guidance interpretive rules issue IVDs Management Branch manufacturing practices MCINTOSH MDMA medical device industry Medical Device Manufacturers medical technologies notiﬁed body off-label Omnicarbon oversight patients pedicle screw physicians premarket review procedures product approval public input public participation pyrolytic carbon question reference list regulations requests requirements response result risk safe and effective safety SCHULTZ SHAYS signiﬁcant SOUDER speciﬁc standards stent Subcommittee submission substantial Thank Thoracotomy triage Ventricular Assist Device warning letters