Premarket Approval

What is Premarket Approval (PMA)?

Premarket approval (PMA) is the most rigorous approval process for medical devices in the United States. It is upheld by the Food and Drug Administration (FDA) and required for a small percentage of devices deemed to be risky.

Class III devices have a high risk, and because of this, the FDA requires a PMA application for these devices to obtain marketing approval. The FDA provides PMA if sufficient scientific evidence shows that the device is safe and effective.

When is a PMA needed?

The PMA is a way for the FDA to evaluate the effectiveness and safety of Class III medical devices, which are those that:

  • support or sustain human life

  • play an important role in preventing impairment of human health
  • possess a potential, unreasonable risk of injury or illness

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