FDA Compliance for Orthokeratology (Ortho-K) Lenses

Orthokeratology (Ortho-K) lenses are specialty contact lenses designed to temporarily reshape the cornea to reduce myopia (nearsightedness), particularly in children & young adults. Due to their overnight wear & direct impact on corneal structure, these lenses are classified as medical devices by the FDA & require strict compliance with safety, labeling & clinical testing regulations.

Manufacturers & distributors must ensure that Ortho-K lenses comply with FDA regulations, including 510(k) clearance, sterility testing & UDI compliance, to legally sell them in the US market. Failure to meet regulatory requirements can lead to Import Alerts, detentions, regulatory fines & enforcement actions.

How the FDA Classifies Orthokeratology Lenses

Class II (Moderate Risk, Requires 510(k) Clearance): Most Ortho-K lenses fall under Class II medical devices, requiring 510(k) clearance to demonstrate substantial equivalence to a legally marketed FDA-approved predicate device.
Class III (High Risk, Requires PMA): Ortho-K lenses that incorporate drug delivery systems, antimicrobial coatings or advanced corneal reshaping technology may be classified as Class III devices, requiring Premarket Approval (PMA) & extensive clinical trials.

All Ortho-K lenses must be prescribed by an eye care professional, as the FDA prohibits over-the-counter (OTC) sales.

Key FDA Compliance Requirements for Ortho-K Lens Manufacturers

To legally market Ortho-K lenses in the US, manufacturers must comply with the following:

Establishment Registration: All manufacturers & importers must register annually with the FDA.
Medical Device Listing: Each Ortho-K lens model must be listed in the FDA’s medical device database.
510(k) Clearance or PMA Submission: Standard lenses require 510(k) clearance. Advanced lenses may require PMA.
UDI Compliance: All Ortho-K lenses must have UDI labeling for tracking & recall readiness.
Sterility & Biocompatibility Testing: Lenses must meet ISO 10993 standards for cytotoxicity, irritation & microbial safety.
Labeling & Advertising Compliance: Marketing materials must be FDA-compliant, free from misleading claims & clear on intended use.
Import Alert Prevention: Foreign manufacturers must ensure full compliance prior to importation.

Common Compliance Challenges & Solutions

Case Study: 510(k) Clearance Rejected Due to Incomplete Clinical Data

A manufacturer submitted a 510(k) application for an Ortho-K lens but lacked long-term reshaping data. The FDA required:

Additional clinical trials on long-term corneal health.
A revised 510(k) with updated safety & performance data.
A launch delay of over nine months due to compliance oversights.

Solution: Manufacturers should conduct thorough clinical testing & submit complete data before applying for clearance.

Case Study: Import Detention Due to Missing UDI Compliance

A foreign manufacturer shipped Ortho-K lenses without UDI labeling, leading to detention. To resolve the issue, the company:

Redesigned packaging to include UDI labels.
Updated device listings.
Worked with regulatory specialists to clear shipments & prevent repeat detentions.

Solution: UDI compliance is mandatory & must be confirmed before importation.

Regulatory Considerations for Ortho-K Lens Manufacturers

FDA User Fees: Required annually; Small Business Fee Assistance may apply.
Import Alerts & Detentions: Non-compliant lenses may be blocked from entry.
Certificate to Foreign Government (CFG): May be needed for exporting FDA-cleared products.
Health Canada Licensing: An MDEL may be required for Canadian distribution.

How to Avoid FDA Compliance Pitfalls

Secure Proper FDA Classification & Clearance – Obtain 510(k) or PMA approval before market entry.
Enforce Prescription Requirements – Sell only with valid prescriptions.
Verify UDI Compliance – Packaging must include Unique Device Identifiers.
Ensure Accurate Labeling – Avoid misleading claims & follow FDA guidance.
Work with Regulatory Experts – Partnering with experts prevents costly mistakes & delays.

Bringing Vision to Market Through FDA Compliance

Orthokeratology lenses offer a non-surgical solution for myopia control, but only with full FDA compliance. From classification & clinical trials to UDI labeling & prescription enforcement, every step matters.

Registrar Corp helps Ortho-K lens manufacturers navigate FDA regulations, meet compliance goals & bring their lenses to the US market with confidence.

Marco Theobold

A highly regarded expert in medical device and drug regulations by the U.S. Food & Drug Administration (FDA), Marco brings a unique perspective for medical device and drug companies seeking to distribute products in the United States. He proudly provides guidance on FDA regulations for pharmaceutical, medical device, and radiation emitting device (RED) companies.