Medical Devices: Draft “The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles;” Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles." In this draft guidance, FDA sets forth its interpretation of the provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA) that require FDA to take into account the least burdensome means for applicants to demonstrate a device's effectiveness or substantial equivalence. This guidance is neither final nor is it in effect at this time.