522 Postmarket Surveillance Studies Database

The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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PSS

General
Study Status	Terminated
522 Number / Requirement Number	PS130016 / PSS001
Date Original Plan Accepted	03/18/2013
Study Name	PSS
Device Name	Ophira mini sling system
Root Document Number	K110420
General Study Protocol Parameters
Study Population
Detailed Study Protocol Parameters
Study Objectives	The manufacturer changed the indications for use and therefore the 522 order no longer applied to this device.

Contact Us

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Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act, Guidance for Industry and Food and Drug Administration Staff
• 522 Program Background