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U.S. Department of Health and Human Services

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Cumulative percent of approved 180-day PMA supplement review memos posted during the month (1)

Cumulative FY 2010 Target: 80%

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 PMA supplement is a supplemental application to an approved PMA for approval of significant changes that affect the safety and effectiveness of the device. This measure quantifies ODE’s ability to inform the public of the status of 180-day PMA supplements for which the sponsor is seeking approval to a change or modification of an approved PMA. Expedient posting of review memos will provide transparency to the public regarding modifications to PMA devices.

Fiscal Year - 2010

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Cumulative FY 2010 Target: 80%

TimeTargetPercent
Jan 2010800
Feb 2010800
Mar 2010800
Apr 20108063
May 20108050
Jun 20108094
Jul 20108094
Aug 20108094
Sep 20108090

FY 2010 Overall: 90%

Footnotes

  • (1) Measure was implemented starting January 1, 2010.

Number of approved 180-day PMA supplement review memos posted during the month

Fiscal Year - 2010
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TimeTargetNumber
Jan 2010N/A0
Feb 2010N/A0
Mar 2010N/A0
Apr 2010N/A5
May 2010N/A3
Jun 2010N/A8
Jul 2010N/A0
Aug 2010N/A0
Sep 2010N/A3

FY 2010 Total: 19

Number of approved 180-day PMA supplements during the month

Fiscal Year - 2010
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TimeTargetNumber
Jan 2010N/A5
Feb 2010N/A0
Mar 2010N/A0
Apr 2010N/A3
May 2010N/A8
Jun 2010N/A1
Jul 2010N/A0
Aug 2010N/A0
Sep 2010N/A4

FY 2010 Total: 21

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.