Many changes are coming to the US Food and Drug Administration (FDA) by virtue of the passage of the 21st Century Cures Act, the recent confirmation of a new commissioner, and the current administration in Washington, DC, that is inclined toward reducing regulation, a key function of this agency. The clinical community depends on high-quality evidence about medical products, and regulatory oversight is a key mechanism for ensuring collection of that evidence. This point becomes especially apparent when important data to guide care are lacking, as illustrated by the recent example of power morcellators.