U.S. PRE-MARKET APPROVALS
 
 
Premarket approval (PMA) is the FDA process for evaluating the safety and effectiveness of Class III medical devices. Class III medical devices are considered to be the highest risk devices and are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
 
 
A company must receive FDA approval of its PMA application prior to marketing the device. This approval is based on a determination that the PMA contains sufficient valid scientific information to assure that the device is safe and effective for its intended use(s)
 
 
Gemar is uniquely qualified to assist you in every step of the PMA process including:
  
  • Assisting you in compiling the necessary information for the submission
  • Participating in telecons and face-to-face discussion meetings with the FDA
  • Submitting the PMA application to the FDA
  • Responding to questions from the FDA
  • Preparing for an advisory committee meeting
  • Arranging 'pre-sub' calls, submissions and meetings with FDA to discuss upcoming submissions