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.
4. Where can I get definitions for the terms used on the Postmarket Surveillance webpage?
Definitions for Study Status and Applicant’s Reporting Status are available in our PAS guidance document entitled, “Procedures for Handling Post-Approval Studies Imposed by PMA Order,” which is available on this webpage.
5. 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.
6. Can a device have more than one requirement related to it?
Yes, there can be more than one requirement imposed by the 522 order.
7. How can I obtain a copy of the 522 order?
The 522 orders, can be requested through FOI at Freedom of Information Act: How to Make a FOIA Request.
8. How can I obtain a copy of a 522 plan or final report?
Protocols and final study reports can be requested either directly from the applicant or from FDA under the Freedom of Information Act (5 U.S.C. 552) (FOIA). FDA will comply with the requirements of 21 CFR Part 20 on the disclosure of information.
9. Whom can I contact if I have additional questions?
If you have any questions or comments related to postmarket surveillance 522 studies or this webpage, please send them to the 522 Postmarket Surveillance Project Manager at email@example.com or to the Associate Director, Program Operations firstname.lastname@example.org