The U.S. Food and Drug Administration (FDA) has recently updated its list of recognized voluntary standards that can be used to demonstrate compliance with particular requirements for the premarket review and authorization of medical devices.
The FDA’s recognition of national and international standards for compliance purposes has its roots in the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Acts which authorizes the agency to “recognize all of part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet premarket submission requirement.”
Since then, the FDA has recognized more than 1700 different standards for application in the premarket approval process, covering a wide range of medical specialties, including orthopedic applications, in vitro diagnostic testing, anesthesiology, obstetrics and gynecology, urology, and radiology.
As the FDA notes in its 2018 Guidance, titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices,” “the use of consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products.”
