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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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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


 
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General
Study Status Consolidated
522 Number / Requirement Number PS110031 / PSS001
Date Original Plan Accepted 08/16/2013
Date Current Plan Accepted 08/16/2013
Study Name Clinical Study
Device Name Modification to: Fmp metal/metal acetabular insert, models 499-28, 499-34, 499-38
Root Document Number K063414 
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


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

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