Procedures for Handling Post-Approval Studies Imposed by PMA Order: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Published
October 7, 2022
Last updated
October 7, 2022
Description
A guidance document outlining procedures for handling post-approval studies imposed by a PMA order for industry and FDA staff.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)