FDA Launches Its Safer Technologies Program for Medical Devices

The U.S. Food and Drug Administration (FDA) has launched a voluntary program to help speed the review and approval of medical devices and products that are deemed safer than those currently available for the treatment of certain medical conditions.

According to the FDA, the Safer Technologies Program (STeP) is intended for devices “intended to treat or diagnose diseases or conditions that are non-life-threatening or reasonably reversible.” The Program complements the FDA’s Breakthrough Devices Program, which focuses on devices and treatments used in addressing life-threatening or irreversibly debilitating diseases or conditions.

Devices eligible for participation in STeP must meet the following criteria:

  • The device is not eligible for the Breakthrough Devices Program due to the less serious nature of the disease or condition treated, diagnosed, or prevented by the device; and
  • The device should be reasonably expected to improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations that provide for at least one of the following:
    1. A reduction in the occurrence of a known serious adverse event;
    2. A reduction in the occurrence of a known device failure mode;
    3. A reduction in the occurrence of a known user-related hazard or use error; or
    4. An improvement in the safety of another device or intervention.

The FDA has issued a guidance document on STeP which provides additional details on the program.

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