FDA regulation of labeling and promotional claims in therapeutic color vision devices: a tutorial.

Abstract:

: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.

journal_name

Vis Neurosci

journal_title

Visual neuroscience

authors

Drum B

doi

10.1017/s0952523804213256

subject

Has Abstract

pub_date

2004-05-01 00:00:00

pages

461-3

issue

3

eissn

0952-5238

issn

1469-8714

pii

S0952523804213256

journal_volume

21

pub_type

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