FDA and the Medical Device Industry: Hearings Before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, Second Session, March 25 and June 3, 1992, Volume 4
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
U.S. Government Printing Office, Jan 1, 1992 - Medical instruments and apparatus - 297 pages
What people are saying - Write a review
We haven't found any reviews in the usual places.
Material submitted for the record
1 other sections not shown
action Agency Andersen applications approval process Benson bioresearch monitoring breast implants CDRH Center Chairman Chelimsky class III devices clinical trials concerns conducted correct Damaska Device Evaluation Dingell Director disapproval District Office Division Dorney employees enforcement facility fact FDA inspector FDA's firm Food and Drug GMP inspections GMP regulation GMP violations going Hooten implants implementation indicated integrity intraocular pressure investigation Investigational Device Exemptions issues Johnson laser latex look manufacturing practices March 25 medical device NOTIFIED ODE management Office of Device ophthalmologist Orcolon percent premarket approval problems procedures quality assurance question questionnaire radiation radiation therapy recall recommendations regulatory response review process Rowland safety and effectiveness Subcommittee staff submitted substantial equivalence Therac 25 Theratronics tion users x)OTS