MainPremarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report. The measure tracks the number of 180-day PMA Supplements decisions made during the quarter that were within 180 FDA days. It includes only fee-paying 180-day PMA supplements.Percentcolumn0100Target

FY 2011 Overall: 84%

Oct – Dec 20108068Jan – Mar 20118088Apr – Jun 20118092Jul – Sep 201180960100Target

FY 2012 YTD: 92%

Oct – Dec 20118579Jan – Mar 201285100Apr – Jun 20128598Jul – Sep 2012850100Target

FY 2013 YTD: 97%

Oct – Dec 20128597Jan – Mar 201385Apr – Jun 201385Jul – Sep 201385 SubPercent of CDRH (ODE & OIR) 180-Day PMA Supplements decisions made in 180 days or less during the quarterNumbercolumn080Target

FY 2011 Total: 142

Oct – Dec 201039Jan – Mar 201122Apr – Jun 201154Jul – Sep 201127080Target

FY 2012 YTD: 94

Oct – Dec 201126Jan – Mar 201226Apr – Jun 201242Jul – Sep 20120Target

FY 2013 YTD: 38

Oct – Dec 201238Jan – Mar 2013Apr – Jun 2013Jul – Sep 2013 SubPercent of CDRH (ODE & OIR) 180-Day PMA Supplements decisions made in 180 days or less during the quarterNumbercolumn080Target

FY 2011 Total: 169

Oct – Dec 201057Jan – Mar 201125Apr – Jun 201159Jul – Sep 201128080Target

FY 2012 YTD: 102

Oct – Dec 201133Jan – Mar 201226Apr – Jun 201243Jul – Sep 20120Target

FY 2013 YTD: 39

Oct – Dec 201239Jan – Mar 2013Apr – Jun 2013Jul – Sep 2013http://www.fda.gov/AboutFDA/Transparency/track/ucm201070.htmFDA-TRACK CDRH Premarket Dashboardtrack?program=cdrh&id=CDRH-ODE-Percent-180-day-PMA-supplements-decisions-in-180-daysPercent of ODE 180-Day PMA Supplements decisions made in 180 days or less during the quartertrack?program=cdrh&id=CDRH-OIVD-Percent-180-day-PMA-supplements-decisions-in-180-daysPercent of OIVD 180-Day PMA Supplements decisions made in 180 days or less during the quarter਍††਍਍਍਍਍਍਍