Certain devices require specific labeling which may include not only package
labeling, but informational literature, patient release forms, performance testing,
and/or specific tolerances or prohibitions on certain ingredients. The following
devices have additional labeling requirements:
Denture repair or refitting kits 21
CFR 801.405 - Special labeling and directions are listed in this section.
Impact resistant lenses in sunglasses and eyeglasses
21
CFR 801.410 - This section specifies that case hardening of glass lenses,
statistical testing of plastic lenses, "drop ball" testing, and
documentation of these activities are required.
Ozone emission levels 21
CFR 801.415 - This section specifies that ozone emission is restricted
to levels below 0.05 parts per million in certain devices, and not permitted
at all for use in any medical conditions for which there is no proof of safety
or efficacy.
Chlorofluorocarbon propellants 21
CFR 801.417 - This section specifies the use is prohibited except for
use in contraceptive foams and certain metered drug dosage forms as detailed
under 21 CFR 2.125. Special labeling is required on devices using this propellant
as listed under 801.425.
Hearing aids 21
CFR 801.420 - Labeling requirements related to warnings, directions to
dispensers and users, and technical data are contained in this section. Conditions
for sale requirements related to availability of instructional brochures,
patient waivers, and record keeping requirements are contained in 21
CFR 801.421.
Menstrual tampons 21
CFR 801.430 - This section contains those labeling requirements related
to Toxic Shock Syndrome (TSS) information, warnings, and advisories.
Chlorofluorocarbons or other ozone depleting
substances 21
CFR 801.433 - This section contains specific warning statements for all
prescription and restricted devices containing or manufactured with chlorofluorocarbons,
halons, carbon tetrachloride, methyl chloride, or any other Class I substance
designated by the U.S. EPA.
Latex condoms 21
CFR 801.435 - This section contains specific requirements for user labeling
including data related to natural integrity, expiration dating requirements,
storage conditions and inclusion of spermicidal ingredients.
Devices containing natural rubber
21 CFR 801.437 - This section contains information related to the definities
of latex, natural rubber, and human contact and specific informational and
caution requirements and restrictions related to the composition of the device.