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.

• FY 2011
• FY 2012
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Number of 180-day PMA supplement summary review memos posted during the month within 60 days after approval

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	2
Nov 2010	N/A	0
Dec 2010	N/A	4
Jan 2011	N/A	2
Feb 2011	N/A	1
Mar 2011	N/A	0
Apr 2011	N/A	16
May 2011	N/A	15
Jun 2011	N/A	12
Jul 2011	N/A	1
Aug 2011	N/A	3
Sep 2011	N/A	8

FY 2011 Total: 64

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

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	2
Nov 2010	N/A	2
Dec 2010	N/A	4
Jan 2011	N/A	2
Feb 2011	N/A	1
Mar 2011	N/A	0
Apr 2011	N/A	16
May 2011	N/A	18
Jun 2011	N/A	13
Jul 2011	N/A	7
Aug 2011	N/A	4
Sep 2011	N/A	8

FY 2011 Total: 77