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U.S. Department of Health and Human Services

About FDA

Percent of 180-day PMA supplement summary review memos posted on the web within 60 days from approval to posting during the month

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 - 2012

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TimeTargetPercent
Oct 201190100
Nov 201190100
Dec 201190100
Jan 20129050
Feb 201290100
Mar 201290N/A
Apr 201290100

FY 2012 YTD: 79%

Number of 180-day PMA supplement summary review memos posted during the month within 60 days after approval

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A5
Nov 2011N/A4
Dec 2011N/A4
Jan 2012N/A6
Feb 2012N/A1
Mar 2012N/A0
Apr 2012N/A3

FY 2012 YTD: 23

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A5
Nov 2011N/A4
Dec 2011N/A4
Jan 2012N/A12
Feb 2012N/A1
Mar 2012N/A0
Apr 2012N/A3

FY 2012 YTD: 29

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.