PMA/510k Booklet

Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. PMA regulates most Class III medical device. A PMA is an application submitted for approval to market. PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that ensures medical device safety and efficacy. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).
Regulation also provides for the submission of a humanitarian device exemption (HDE) application. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer people in the United States per year.
The PMA/510k Booklet App presents the regulations for medical device Premarket Approval, 510(k) premarket notification and Humanitarian Use Device in a user-friendly e-format. The users can easily reach to each section of regulations with customized view options. This is a convenient information and reference tool for all people working in medical device and related industry.

Keywords : Premarket Approval, PMA, 510(k), Premarket Notification, Humanitarian Use Device, HUD, FDA, Regulation, Regulatory