Compliance In Focus

Recently FDA Commissioner Scott Gottlieb released a statement on a record year for device innovation. This press release highlights the FDA’s efforts for advancement of medical devices that serve previously unmet medical need, improve quality of life, and in some cases save lives.

Informed consent is a process designed to protect the rights and welfare of a patient while providing a description of risks, alternatives, and any/all pertinent information that may alter a patient’s willingness to participate.