The article describes in detail the regulatory approach to be applied with respect to contact lenses allowed for marketing and use in the US.

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to soft (hydrophilic) daily wear contact lenses. In particular, the document describes the performance criteria for safety and performance-based pathway. The guidance provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. It is important to mention that provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the underlying legislation and has been agreed with the authority in advance. The present guidance is a final version of the document based on the draft initially issued by the FDA earlier in March 2020.

Regulatory Background

The present guidance outlines performance criteria for soft (hydrophilic) daily wear contact lenses placed on the market under the 510(k) premarket notification pathway. The approach described in the guidance allows the applicants to use the performance criteria to support substantial equivalence instead of providing a direct comparison to a similar product already placed on the market. 

The document also references the FDA-recognized voluntary consensus standards medical device manufacturers may refer to to demonstrate compliance with the applicable regulatory requirements. 

Under the general rule, the Safety and Performance Based Pathway could be applied with respect to certain medical devices for which sufficient information is in place. According to this approach, a party interested in placing such a device on the market can demonstrate compliance with the applicable regulatory requirements by demonstrating that the product meets specific performance criteria identified by the authority instead of providing a comparison to a similar medical device already allowed for marketing and use in the US. As explained in the document, in order to identify the specific set of performance criteria appropriate to satisfy a submitter’s comparison to an appropriate predicate for a given device type, FDA has determined that the performance criteria represent performance that meets the performance of one or more existing, legally marketed devices of that device type. In particular, the authority mostly relied on its experience and expertise, as well as information available in the literature and the analysis of data available to the authority regarding similar products already placed on the market. The authority acknowledges that providing such a comparison in certain cases could constitute an additional burden for the applicant while demonstrating that the product in question meets respective performance criteria will facilitate and streamline the regulatory procedures. Thus, the approach described in the document is expected to be the least burdensome and beneficial for the industry.

Applicability Scope

The products covered by the scope of the present guidance are daily wear contact lenses subject to regulation as Class II medical devices under 21 CFR 886.5925 (product code LPL). They are prescription devices designed to be replaced frequently (on a daily basis). At the same time, the authority explicitly states that certain contact lenses fall outside the scope of the document – in particular, the ones intended:

  • To correct presbyopia;
  • To enhance or alter the apparent color of the eye;
  • To act as a bandage or therapeutic lens;
  • For the management of keratoconus or irregular corneal conditions;
  • Lenses with special optical performance beyond that of correcting ametropia (e.g., blue light filtering);
  • Lenses with special physical performance (e.g., retains moisture, lubricates, reduces deposits);
  • Lenses with special health performance characteristics (e.g., relieving dry eye).

Design Characteristics

The guidance further highlights the key design characteristics for contact lenses covered by its scope. Usually, such products are manufactured using polymacon, etafilcon A, or hioxifilcon D polymeric materials and are supplied in primary packaging. The aforementioned materials are widely used for such products. It is also important to mention that color additives could be used only for handling and visibility tinting. 

The authority additionally emphasizes that rigid gas-permeable contact lenses and soft contact lens materials are falling outside the scope of the present guidance. The same applies to:

  • Lenses made of materials not defined above;
  • Lens materials made of non-polymeric components;
  • Lens materials with non-listed color additives;
  • Lenses with UV-additives not previously used in polymacon, etafilcon A, or hioxifilcon D materials;
  • Lenses with coatings, whether directly or indirectly applied (e.g., wetting agents applied by immersion in packaging solution);
  • Lenses with novel packaging solution ingredients not used in any previously marketed contact lens packaging solution or care product;
  • Lens materials with special optical filtering capabilities (e.g., blue light filtering);
  • Lenses with new spherical or toxic optical designs that have not previously been marketed;
  • Combination products. 

Recommendations provided in the guidance could also be taken into consideration for complying with the special control for soft dairy wear contact lenses. The authority refers to the respective guidance document for further details on the matter. 

In summary, the present guidance provides an overview of the existing regulatory framework for daily wear contact lenses. The document highlights the key points to be considered by medical device manufacturers to ensure compliance with the respective requirements and be eligible for placing their products on the market under the least burdensome pathway.

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