The PMA route
Class III devices are devices which employ novel methods or technology, or has a new intended use, and whose safety and effectiveness have not yet been validated. The approval of such a device requires the submission to the FDA of a Pre-Market Approval (PMA) file. Since there exists no predicate device of proven characteristics, it is the sponsors onus to present in the PMA submission complete and convincing evidence to show that the new technology is safe and effective.
The regulatory route of Class III devices is the longest and most demanding of all classes. Therefore, careful planning, performance and submission of data, are of crucial significance in the case of PMA devices.
The time it may take to obtain a Pre-Market Approval from FDA may take up to 24 months.
The Regulatory Designated Agent
Companies that import medical devices into the United States need to appoint a
Regulatory Designated Agent. The Food and Drug Administration Modernization Act of 1997 (FDAMA) requires that "any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a
device that is imported into the United States shall register with [FDA] the name and place of business of the establishment and the name of the United States agent for the establishment". The role of a U.S.
Regulatory Designated Agent under the regulations requires that it be authorized to speak with FDA on behalf of the company, and to discuss proprietary information about the company.
For more information on the
Regulatory Designated Agent please go to the
Medes USA Inc. website.
Quality System Requirements
You will need to establish and maintain a Medical Quality Management System, compliant with the cGMP/QSR requirements, as described in 21 CFR Part 820.
For more information on the QSR go to the
FDA QMS Requirements section
