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U.S. Department of Health and Human Services

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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 - 2011

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TimeTargetPercent
Oct 201090100
Nov 2010900
Dec 201090100
Jan 201190100
Feb 201190100
Mar 201190-
Apr 201190100
May 20119083
Jun 20119092
Jul 20119014
Aug 20119075
Sep 201190100

FY 2011 Overall: 83%

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A2
Nov 2010N/A0
Dec 2010N/A4
Jan 2011N/A2
Feb 2011N/A1
Mar 2011N/A0
Apr 2011N/A16
May 2011N/A15
Jun 2011N/A12
Jul 2011N/A1
Aug 2011N/A3
Sep 2011N/A8

FY 2011 Total: 64

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

Fiscal Year - 2011
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2010N/A2
Nov 2010N/A2
Dec 2010N/A4
Jan 2011N/A2
Feb 2011N/A1
Mar 2011N/A0
Apr 2011N/A16
May 2011N/A18
Jun 2011N/A13
Jul 2011N/A7
Aug 2011N/A4
Sep 2011N/A8

FY 2011 Total: 77

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.