Assuring Safety, Effectiveness QUALITY: Premarket Requirements

Safety, effectiveness and quality are the watchwords of the medical technology industry, and companies commit significant time and expertise to ensure that their devices perform as intended. This commitment starts at the earliest design phase and continues through the development, manufacturing and distribution of a device.

The universe of medical technology is vast – including everything from simple examination tools to sophisticated imaging and monitoring equipment – so FDA has developed a risk‑based premarket review system that determines the level of review based on the device type. Every year the agency subjects thousands of medical devices to extensive science-based reviews to ensure that they meet their pre-determined specifications. This approach is a model for medical technology regulation worldwide.

There are two main pathways to market:

  • Low-to moderate-risk device types that have a well-established safety profile are cleared through the premarket notification or 510(k) process.
  • Higher-risk technologies that often involve novel or first-of-a-kind innovations follow the premarket approval (PMA) application process.

Regardless of the pathway, FDA determines the evidence necessary before any new device or diagnostic can be deemed safe and effective, and the data that companies need to provide is comprehensive and thorough.

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FDA Fact Sheets

premarket notification 510(k)

510(k) Myths vs. Facts

FDA requirements for medical technology (Infographic)