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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Registry Database

General
Study Status	Redesigned/Replaced Study
522 Number / Requirement Number	PS110002 / PSS001
Date Original Plan Accepted	08/23/2013
Date Current Plan Accepted	03/16/2016
Study Name	Registry Database
Device Name	Tmj fossa-eminence/condylar prosthesis system
Root Document Number	P000023  P000035
General Study Protocol Parameters
Study Population	Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives	This study design was revised/replaced by the other remaining PS Requirements.

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