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.
On this page:
- Section 522 Postmarket Surveillance Requirements
- 522 Postmarket Surveillance Studies Database
- Obtaining 522 Orders, Plans, and Reports
- Contact Information
- Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff (PDF - 528KB).
Section 522 Postmarket Surveillance Requirements
Section 522 of the Federal Food, Drug and Cosmetic Act (the act) gives the FDA the authority to require a manufacturer to conduct postmarket surveillance of a class II or class III device that meets any of these criteria:
- Its failure would be reasonably likely to have serious adverse health consequences.
- It is expected to have significant use in pediatric populations.
- It is intended to be implanted in the body for more than one year.
- It is intended to be a life-sustaining or life-supporting device used outside a device user facility.
The FDA has established an automated 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 FDA and applicants. This system represents the FDA's effort to ensure that all 522 postmarket surveillance commitments are fulfilled in a timely manner.
Note: A device may have more than one requirement imposed by the 522 order.
522 Postmarket Surveillance Studies Database
CDRH launched the 522 Postmarket Surveillance Studies Database to keep all stakeholders informed of the progress of each 522 postmarket surveillance study.
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.
Searching and Sorting the Database
Search: You can search the database for all orders by manufacturer, device name, medical specialty, or 522 order number. To search the database, type the search term in the search field and click Search.
Sort: You can sort the database by manufacturer, device name, 522 order number, or date 522 order.
- Click the button for the type of orders you want to sort: Active, Inactive, or All Orders.
- Click the arrow in the column heading to sort the displayed orders.
Terms Used in the Database
For definitions of terms used in the database, refer to the guidance, Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.
- Study Status in the database is listed as Postmarket Surveillance Status Determination in the guidance.
- Applicant’s Reporting Status in the database is listed as Manufacturer’s Reporting Status in the guidance.
Updates to Study Information in the Database
The FDA updates the 522 Postmarket Surveillance Studies Database monthly based on any new or revised information on study protocol parameters (for example, patient population) or the review of data from interim or final reports. While most data elements in the database are not expected to change after the initial entry, overall study status and information related to the applicant's reporting status are.
Obtaining 522 Orders, Plans, and Reports
To obtain a 522 order, you will need to submit a FOIA request to the FDA. For more information, see Freedom of Information.
To obtain a 522 plan (including protocols) or final study report, you may:
- Submit the request directly to the manufacturer.
- Submit a FOIA request to the FDA. For more information, see Freedom of Information Act: How to Make a FOIA Request
Mandated Studies Program
U.S. Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Email: [email protected]