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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Clinical Study

General
Study Status	Consolidated
522 Number / Requirement Number	PS110035 / PSS001
Date Original Plan Accepted	08/16/2013
Date Current Plan Accepted	08/16/2013
Study Name	Clinical Study
Device Name	Metal backed acetabular component
Root Document Number	K950542
General Study Protocol Parameters
Study Design	Cross-Sectional Study
Data Source	New Data Collection
Comparison Group	Concurrent Control
Analysis Type	Analytical
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	The manufacturer has requested to consolidate their multiple 522 orders into one. The original order has been amended to include these devices in one study that will fulfill the 522 order. This device is now included in PS110029.

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