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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Bateman Bottle Postmarket Surveillance Study

General
Study Status	Noncompliant
522 Number / Requirement Number	PS230003 / PSS001
Study Name	Bateman Bottle Postmarket Surveillance Study
Device Name	Breast Implant Removal Device (BIRD) previously the Bateman Bottle
Root Document Number	DEN220082
General Study Protocol Parameters
Study Population

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