The applicant must receive FDA approval of its PMA application prior to marketing the device. The FDA bases a PMA approval on a determination that the submission contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use.

The PMA application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the class III device. There are administrative elements of a PMA application, but good science and scientific writing is a key to the approval of the PMA application.

A PMA normally comprises the following information:

• Device Decription
• Intended Use
• Principles of Operation
• Properties of the Device
• Results of Non-Clinical Studies
• Quality Controls
• Clinical Data

PROSYSTEM supports you during the entire PMA process:

• Development of a Submission Strategy
• Development of a Project Plan
• Identification of required Information 
• Preparation and monitoring of clinical trials
• Compilation of the PMA Documentation
• Communication with the FDA during the Application Phase
• Preparation of the FDA Meetings

Benefit from our experience in numerous PMA-Projects.

Contact us for further information or a non-binding quotation