Description
This guidance document provides the FDA's recommendations on performance criteria to support premarket submissions for soft (hydrophilic) daily wear contact lenses in the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using theSafety and Performance Based Pathwayfor soft (hydrophilic) daily wear contact lenses will have the option to use the performance criteria proposed in this final guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of soft (hydrophilic) daily wear contact lenses.
Scope & Applicability
Product Classes
4Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Subject of the performance criteria guidance
Categorization for devices covered by this guidance
Regulatory Context
Attributes
2Standard for 510(k) clearance
Contact duration of ≤ 24 hours
Related CFR Sections (2)
- 21CFR886.5925§ 886.5925 Soft (hydrophilic) contact lens.
(a) Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules Read full regulation →
- 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 →
See Also (2)
- Contact Lens Care Products Labeling: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)