522 Postmarket Surveillance Studies – Frequently Asked Questions (FAQs)
1. When does FDA require 522 postmarket surveillance?
Section 522 of the Federal Food, Drug and Cosmetic Act (the act) gives FDA the authority to require a manufacturer to conduct postmarket surveillance of a class II or class III device that meets any of the following 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; or
- it is intended to be a life-sustaining or life-supporting device used outside a device user facility.
2. Why is FDA providing the 522 webpage?
The purpose of this webpage is to ensure that stakeholders have access to current information about 522 postmarket surveillance studies that were required by FDA.
3. How can I search and/or sort the 522 webpage?
You can find information by:
- selecting one of the alphabetical buttons at the top of the page to go directly to the applicant names that begin with that letter; or
- sorting the data in ascending or descending order by clicking one of the arrows in the column headers:
- 522 Application Number
- Applicant Name
- Device Name
- Medical Specialty
- Date 522 Order
- Study Status.
4. How often will the 522 webpage be updated?
We intend to update the webpage on the 5th of every month based on any new or revised information on study protocol parameters (e.g., patient population) or the review of data from interim or final reports. While most data elements in the webpage table are not expected to change after the initial entry, overall study status and information related to the applicant’s reporting status are.
5. Whom can I contact if I have additional questions?
If you have any questions or comments related to the 522 postmarket surveillance studies program or this webpage, please send them to the Senior Scientific Project Manager, Nathan S. Ivey, PhD at Nathan.Ivey@fda.hhs.gov.