FDA Guidances on Physician-Directed Use

William M. Mihalko, MD, PhD; Katherine Sale, MPH; ; S. Raymond Golish, MD, PhD, MBA

The U.S. Food and Drug Administration (FDA) has issued several guidances—documents that outline the agency's current thinking about regulatory policy—concerning physician-directed use of medical devices. Before a guidance is finalized, the agency releases a draft guidance to solicit feedback from stakeholders. In January 2017, the FDA issued two new draft guidances, using a question/answer format.