The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the safety and performance-based pathway. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved. It is important to mention that guidance documents issued by the FDA do neither introduce new rules, nor impose new obligations, and the provisions thereof are non-binding in their legal nature. As it is mentioned by the FDA, an alternative approach could be also applied, provided such an approach complies with the respective regulatory requirements and has been agreed with the authority in advance.
The present article is dedicated to the Abbreviated 510(k) Program to be applied when demonstrating substantial equivalence to medical devices already placed on the market (predicates). As it is explained by the Agency, the guidance intends to describe an optional pathway – the Safety and Performance Based Pathway – for certain, well-understood device types, where a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device.
First of all, the Agency provides additional clarifications regarding the concept of substantial equivalence, which refers to the similarity in terms of technical characteristics, as well as safety and effectiveness. The parties interested in placing new medical devices on the US market may refer to substantial equivalence to similar medical devices already allowed for marketing and use in the country to facilitate the regulatory procedures. The authority also mentions that apart from the general 510(k) pathway, several alternative programs could be used in specific cases: the Special 510(k) and the Abbreviated 510(k). The latter refers to the special controls, as well as the applicable FDA-recognized voluntary consensus standards the applicants may refer to when demonstrating that the device meets the applicable regulatory requirements. The 510(k) process is aligned with the “least burdensome” approach which provides that the regulatory burden is reduced to the minimum extent necessary to ensure the safety and effectiveness of medical devices intended to be placed on the market.
The authority acknowledges that in certain cases direct comparison with a predicate creates an additional regulatory burden. Moreover, there could be certain technological differences to be taken into consideration. Thus, the Abbreviated 510(k) Program is intended to overcome the aforementioned issues and make the application review process more efficient, as well as to reduce the time such a review requires. For instance, in certain cases, direct testing and comparison concerning specific performance and technological characteristics require more time and effort than comparison based on key safety and performance criteria set forth by the FDA.
According to the applicable legislation, the concept of substantial equivalence is based on the comparison between two medical devices: the one already placed on the market and the new one which is subject to review. At the same time, as further explained by the FDA, such a comparison should not be limited to direct comparison, as its results could be impacted significantly by the technological differences, but should be based on performance review. The main purpose of the process is to demonstrate that the new medical device is as safe and efficient as the existing one. Hence, instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence based on data showing the new device meets the level of performance of appropriate predicate device(s). Thus, by the approach described in the present guidance, a party interested in placing its product on the market should demonstrate that it meets the applicable performance criteria as outlined in respective guidance documents issued by the FDA, consensus standards, and special controls. The authority also mentions that medical devices that meet eligibility criteria for both the Third-Party Review Program and the Safety and Performance Based Pathway remain eligible for both frameworks.
The specific performance criteria the applicant refers to should apply to at least one medical device already placed on the market. The applicant shall demonstrate that the product in question is at least as safe and effective as an existing one. At the same time, the authority also mentions that direct comparison of a new device with a legally marketed device would remain available under a Traditional or Special 510(k) pathway, as appropriate, including for those devices eligible for the 510(k) Third Party Review Program, while in case of applying the framework described herein, attention should be paid to performance criteria. Hence, the product should be evaluated as a whole, instead of direct comparison based on specific characteristics.
The regulating authority further outlines the eligibility criteria for applying the new performance-based framework. According to the guidance, the use of performance criteria is only appropriate when FDA has determined that:
- The new device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate,
- The performance criteria along with the performance of one or more legally marketed devices of the same type as the new device, and
- The new device meets all the performance criteria.
The FDA explicitly mentions that a submitter is entitled to choose a testing methodology different from the one initially recommended. The applicable performance-based criteria to be used in the context of the new framework would be prescribed by the respective guidance document issued by the FDA. According to the guidance, in case the application of these criteria is not sufficient for a comprehensive evaluation of the safety and effectiveness of a new product, such a product would not be eligible for this framework. However, such a product could still be placed on the market under another 510(k) pathway, e.g. Traditional, Special, or Abbreviated.
In summary, the present FDA guidance describes the regulatory framework based on performance review and comparison to be carried out to identify whether the product subject to review meets the appropriate safety and performance criteria. The document highlights the most important aspects to be taken into consideration when determining the eligibility for the new framework.
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