Past, present, and future regulatory aspects of ventricular assist devices.
The development of ventricular assist devices (VADs) for the treatment of heart failure has been ongoing since the National Heart Lung and Blood Institute (NHLBI) initiated the artificial heart program in 1964. The primary goal was to develop VADs and total artificial hearts for both temporary (short-term) and long-term use. Due to a small target population and the inability to blind patients and clinicians, the Food and Drug Administration (FDA) has recognized the challenges of conducting trials with these invasive devices. In an effort to address those challenges, FDA has accepted a variety of clinical trial designs to collect the data required to evaluate safety and effectiveness data in different patient groups. This article will provide a detailed discussion of the past, present, and future FDA regulatory considerations for VADs.
Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA. sonna.patel@fda.hhs.gov
Sonna M
SM
Patel-Raman
Eric A
EA
Chen
D002986:Clinical Trials as Topic; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards*; D019317:Evidence-Based Medicine; D033161:Government Regulation; D006333:Heart Failure / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects / Q000592:standards*; D006801:Humans; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D011474:Prosthesis Design; D018570:Risk Assessment; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards*