The new article highlights the aspects related to specific tests to be conducted by medical device manufacturers in order to demonstrate compliance with the applicable regulatory requirements.
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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. The document outlines the performance criteria for safety and performance-based pathway. It is important to mention that guidance documents issued by the FDA are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide 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. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with existing legislation and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the aspects related to testing performance criteria.
Testing Performance Criteria: Key Points
First of all, the authority states that in the case (i) the device in question is eligible for the Safety and Performance Based Pathway, and (ii) its manufacturer decides to apply the said approach, a direct comparison with a similar medical device placed on the market (predicate) provided to demonstrate substantial equivalence will not be required. Instead, the manufacturer may provide a results summary for all the tests conducted in order to demonstrate that the device meets the respective performance criteria, together with the Declaration of Conformity (DoC) and other information and documentation. Furthermore, the authority reserves the right to request additional information and data should it be reasonably necessary to assess compliance with the applicable safety and performance criteria. The aforementioned results summary should be submitted as part of the 510(k) submission. In this respect, the authority refers to a separate guidance document dedicated to the content and format of non-clinical bench performance testing information to be included in premarket submissions.
The document further outlines specific criteria related to the safety and performance medical device manufacturers should take into consideration when placing their products on the market. The guidance also describes specific tests to be completed in order to assess compliance with the respective regulatory requirements. In particular, the document describes the tests addressing such aspects as:
- Physicochemical and optical properties;
- Mechanical properties;
- Packaging solution;
- Sterilization;
- Biocompatibility.
Biocompatibility in Detail
Due to contact lenses being medical devices intended to be in contact with a patient’s tissue, and also due to the extent and duration of such contact, the authority pays special attention to the aspects related to biocompatibility.
In terms of biocompatibility, the guidance refers to the International Standard ISO 10993-1 and relevant guidance documents issued by the FDA to explain the way the said standard should be applied. According to the guidance, medical devices described therein are considered “surface devices with a limited mucosal membrane contact duration of up to 24 hours”.
The list of specific aspects to be addressed, together with the applicable FDA-recognised standards, includes:
- Cytotoxicity – ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity;
- Sensitization – ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization;
- Ocular Irritation – ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization; ISO 10993-23 Biological evaluation of medical devices – Part 23: Tests for irritation.
As further explained by the authority, should the medical device in question be manufactured from identical black polymer buttons and identical packaging materials using identical manufacturing processes as a predicate device with the same type and duration of tissue contact, and any changes in device design are not expected to impact the biological response, this is typically sufficient to establish substantially equivalent biocompatibility.
In certain cases, medical device manufacturers may determine that additional testing is required to assess specific endpoints. In such cases, the authority encourages medical device manufacturers to provide complete test reports for all the tests conducted with respect to both contact lenses themselves as well as any packaging materials used. According to the guidance, any test-specific positive, negative, and/or reagent controls should perform as expected, and protocol deviations should be thoroughly described and justified; however, […] certain protocol deviations may invalidate comparison to the performance criteria […] resulting in the need for submission of a Traditional, Special, or Abbreviated 510(k).
In summary, the present FDA guidance describes in detail the approach to be applied when placing soft (hydrophilic) daily wear contact lenses on the market under the Safety and Performance-Based Pathway. The pathway is intended to reduce the regulatory burden for medical device manufacturers and facilitate and streamline the regulatory procedures associated with placing new products on the market. The present guidance outlines the key points to be taken into consideration by medical device manufacturers with respect to safety- and performance-related criteria a product should meet in order to be allowed for marketing and use in the US.
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