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 (FD&C Act). The program helps ensure that well-designed 522 postmarket surveillance studies are conducted effectively, efficiently, in the least burdensome manner, and result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health and will answer surveillance questions.
On this page:
- Section 522 Postmarket Surveillance Requirements
- 522 Postmarket Surveillance Studies Database
- Obtaining 522 Orders, Postmarket Surveillance Plans, or Reports
- Contact Information
Related page:
Section 522 Postmarket Surveillance Requirements
Section 522 of the FD&C 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 postmarket surveillance plans and agreed upon by the FDA and manufacturers. 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 established the 522 Postmarket Surveillance Studies Database to share information (such as study description, interim and final study results) regarding each 522 postmarket surveillance study.
The database also provides the overall study status (based on timelines set in the 522 order, approved postmarket surveillance plan, and adequacy of the data), and the manufacturer’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, or 522 order number. To search the database, type the term in the search field and click Search.
Sort or Filter: You can sort the database by manufacturer, device name, medical specialty, 522 order number, or date of 522 order. You can also filter the 522 orders by their status (active, inactive, and all orders).
- To filter the 522 orders, click the button for the type of orders you want to sort: Active, Inactive, or All Orders.
- To sort, 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 may include terms not specified in the guidance (“Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act”) as the terms in the guidance apply to new submissions or new studies received after publication of the final guidance. For an interim period, the status of some studies may be marked as Progress Adequate, Progress Inadequate, Other, or Revised/Replaced, reflecting prior policy, until new information is submitted to FDA for review and the study status category is changed.
- Applicant’s Reporting Status in the database is identified as Manufacturer’s Reporting Status in the guidance.
Updates to Study Information in the Database
The FDA updates the 522 Postmarket Surveillance Studies Database every Sunday with new 522 requirements, new or revised study information (for example: plan parameters, study status, or interim or final data summary), study enrollment status or reporting status.
Obtaining 522 Orders, Plans, and Reports
To obtain a 522 order, postmarket surveillance 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
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