FDA Releases Draft Guidance on Medical Devices: 'Evidence Models for the Least Burdensome Means to Market'

Summary

The FDA has published a draft guidance document aimed at streamlining the premarket development and review process for medical devices, in line with the requirements of the Food and Drug Administration Modernization Act of 1997 (FDAMA). The guidance is intended to help manufacturers and FDA reviewers navigate the 'least burdensome' means to market, reducing unnecessary delays and expenses.