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Premarket Approval Applications (PMAs)

Premarket approval (PMA) is the FDA review process to evaluate the safety and effectiveness of Class III medical devices. Class III devices 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 Premarket approval application (PMA) is the most stringent type of device marketing application required by FDA. 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(s).

PMA Submission Details

Information contained in a PMA submission typically includes the following: a device description and indications for use, alternative practices and procedures, marketing history, manufacturing information, reference to any performance standard or voluntary standard, results of nonclinical laboratory studies, results of clinical investigations involving human subjects, and copies of all proposed labeling for the device.

FDA regulations provide 180 days to review the PMA and make a determination, but often, the review time is longer. Before approving or denying a PMA, the appropriate FDA advisory committee may review the PMA at a public meeting and provide the FDA with the committee's recommendation on whether the FDA should approve the submission.

MDCI will assist throughout the PMA process to help you to edit and organize the information to be included in your submission , prepare for and participate in any FDA review meetings and advisory committee meetings, if necessary, and assist you in preparing for FDA inspections of your manufacturing facility.

Contact us today to get help with your PMA Application

Learn More About MDCI's Assistance with Other FDA Submissions Including:

• 510(k) Premarket Notifications
• Investigational Device Exemption Applications (IDEs)
• Investigational New Drug Applications (INDs)
• 513(g) Requests for Classification