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  1. Postmarket Requirements (Devices)

522 Postmarket Surveillance Studies Program

The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance studies are conducted effectively and efficiently and in the least burdensome manner.

CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 postmarket surveillance studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 postmarket surveillance commitments are fulfilled in a timely manner.

For more information, see Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff (PDF - 528KB).

522 Postmarket Surveillance Studies Database

Screen shot of the 522 Postmarket Surveillance Studies database page on FDA.gov

CDRH launched the 522 Postmarket Surveillance Studies Database to keep all stakeholders informed of the progress of each 522 postmarket surveillance study.

Go to the Database

The database displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant’s reporting status for each submission due.

Contact Information

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

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