Premarket approval

Premarket Approval (PMA) is a process of scientific and regulatory review 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.

Overview

Premarket Approval is the Food and Drug Administration (FDA)'s process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. 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. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).

Process

The PMA process is more involved and includes the assessment of clinical trials. The FDA will approve the PMA application if it determines that the application contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use(s).

Requirements

The PMA applicant is required to provide results from clinical investigations, nonclinical laboratory studies and manufacturing information. The FDA uses this information to make a determination about the safety and effectiveness of the device.

See also

• Food and Drug Administration
• Medical device
• Clinical trial
• Regulatory compliance

References

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