Medical Devices: FDA Review Time : Report to the Chairman, Subcommittee on Oversight and Investigations, Committee on Commerce, House of Representatives
The Office, 1995 - Medical instruments and apparatus - 87 pages
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1994 Cardiovascular 28 Total 30 Total 95 Mean appendix applications submitted Approval for pmas Approval Tables III.l Average Days Class of Medical clinical Comments completed Days N Days Days N Percent Days to Approval Days to Decision Days to Equivalency DCRND Decision on Investigational Decision on Original Decision on pma Device and Number Device Exemption Tables DGRD Division DCLD DRAER draft report Drug Administration Equivalency for 510(k)s fda and non-FDA fda clock FDA Decision Codes Figure fiscal year 1989 Food and Drug General/plastic surgery III.18 Table includes open Investigational Device Exemptions median review Medical Device Medical Specialty N Days N number of applications Number of Open Open Cases October Ophthalmic Original PMAs Percent Days pmas by Fiscal Premarket Approval Tables Premarket Notification 510(k review FDA Non-FDA safety and effectiveness Specialty of Device Summary of Average Tier of Medical Total 21 total elapsed Total FDA Non-FDA Total Open Withdrawn Other Total