Category: In vitro Diagnostics Submenu
Hits: 2077
  • Do you have a new medical product that falls into FDA Class III?
  • Are you ready to start your clinical investigation to support US marketing?
  • Unsure of what types of data are necessary for FDA submission?

Premarket approval (PMA) is the FDA process for evaluating the safety and effectiveness of high risk medical devices. 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).
Companies located outside the United States can benefit from GEMAR assistance and support in understanding and responding to U.S. product submission requirements, particularly for complex devices, sterile devices or devices containing software.
GEMAR can help your company by:
  • Assisting with understanding U.S. submission requirements;
  • Providing support and advice during 'pre-sub' communications with FDA;
  • Identifying and obtaining applicable guidance documents and standards, including identification of FDA-recognised standards;
  • Compiling the necessary documentation for the submission;
  • Preparing for and participating in teleconferences and meetings with the FDA review division;
  • Assisting in the development of labeling, including user manuals, that meets U.S. regulatory requirements.
If you have regulatory challenges, we have the solutions. Contact us for your comprehensive service needs.