Description
FDA is issuing this guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. These labeling recommendations are important because misuse associated with these devices has resulted in serious eye injuries. FDA believes that the labeling recommendations in this guidance may help manufacturers develop labeling with information about specific risks and directions for use of the HPCPs in conjunction with a user’s prescribed contact lenses. These labeling recommendations are intended to promote the safe and effective use of HPCPs and ensure that consumers receive and understand information regarding the benefits and risks associated with the use of the device.
Scope & Applicability
Product Classes
3Subject of the guidance regarding consumer labeling recommendations.; Guidance applies to all HPCPs; Guidance for consumer labeling recommendations; HPCP solution described in the labeling example.
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Class III subject to the 510(k) or PMA requirements
Stakeholders
2Entity responsible for submitting NDINs
Professional to be contacted if eye discomfort occurs; Professional to consult for eye problems or lens care; Professional to consult for problems
Regulatory Context
Attributes
3Time product can be safely used after opening
The end point achieved by a sterilizing process.
should be based on appropriate supportive stability data
Identified Hazards
Hazards
4Improper use of HPCPs resulting in serious eye injuries.
Result of improper use or inadequate neutralization
Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water
risk in multidose drug products
Related CFR Sections (9)
- 21CFR886.5918§ 886.5918 Rigid gas permeable contact lens care products.
(a) Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenRead full regulation →
- 21CFR886.5928§ 886.5928 Soft (hydrophilic) contact lens care products.
(a) Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lensesRead full regulation →
- 21CFR801.5§ 801.5 Medical devices; adequate directions for use.
Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specificatiRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR801.60§ 801.60 Principal display panel.
The term principal display panel, as it applies to over-the-counter devices in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall Read full regulation →
- 21CFR801.61§ 801.61 Statement of identity.
(a) The principal display panel of an over-the-counter device in package form shall bear as one of its principal features a statement of the identity of the commodity.Read full regulation →
- 21CFR801.62§ 801.62 Declaration of net quantity of contents.
(a) The label of an over-the-counter device in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight, measure, or size: Provided, That:Read full regulation →
- 21CFR800.12§ 800.12 Contact lens solutions and tablets; tamper-resistant packaging.
(a) General. Unless contact lens solutions used, for example, to clean, disinfect, wet, lubricate, rinse, soak, or store contact lenses and salt tablets or other dosage forms to be used to make any such solutions are packaged in tamper-resistant retail packages, there is the opportunity for the maliRead full regulation →
- 21CFR800.10§ 800.10 Contact lens solutions; sterility.
See Also (8)
- Contact Lens Care Products Labeling: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 396.400 Policy on Warned on Sunlamp Products (Status: Final)
- CPG Sec. 300.300 Ineffective Devices - 502(f)(I) Labeling Requirements (Status: Final)
- Policy on Warning Label Required on Sunlamp Products (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)
- Guidance Document For Nonprescription Sunglasses - Guidance for Industry (Status: Final)
- Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers (Status: Final)