The Food and Drug Administration (FDA) is responsible for determining
whether medical device manufacturers have provided reasonable
assurance, based on valid scientific evidence, that new devices are
safe and effective for their intended use before they are introduced
into the U.S. market. Most existing color vision devices pose so little
risk that their manufacturers are not required to submit a premarket
notification [510(k)] to FDA prior to market. However, even
low-risk devices may not be acceptable if they are marketed on the
basis of misleading or excessive claims. Although most color vision
devices are diagnostic, two types that are therapeutic rather than
diagnostic are colored lenses intended to improve deficient color
vision and colored lenses intended to improve reading performance. Both
of these devices have presented special regulatory challenges to FDA
because the intended uses and effectiveness claims initially proposed
by the manufacturers were not supported by valid scientific evidence.
In each instance, however, FDA worked with the manufacturer to restrict
labeling and promotional claims in ways that were consistent with the
available device performance data and that allowed for the legal
marketing of the device.