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U.S. Department of Health and Human Services

About FDA

Percent of Office of Device Evaluation (ODE) 180-Day PMA Supplements decisions made in 180 days or less during the quarter

Dictionary: Premarket 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.

Information is current as of September 30, 2013

Fiscal Year - 2012

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TimeTargetPercent
Oct – Dec 20118067
Jan – Mar 20128084
Apr – Jun 20128091
Jul – Sep 20128096

FY 2012 Overall: 83%

Number of ODE 180-Day PMA Supplements decisions made in 180 days or less during the quarter

Fiscal Year - 2012
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TimeTargetNumber
Oct – Dec 2011N/A20
Jan – Mar 2012N/A16
Apr – Jun 2012N/A38
Jul – Sep 2012N/A17

FY 2012 Total: 91

Total number of ODE 180-Day PMA Supplements decisions made during the quarter

Fiscal Year - 2012
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TimeTargetNumber
Oct – Dec 2011N/A27
Jan – Mar 2012N/A16
Apr – Jun 2012N/A39
Jul – Sep 2012N/A17

FY 2012 Total: 99

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.