The second article is dedicated to the eligibility criteria the authority will use when determining whether the Safety and Performance Based Pathway could be applied concerning a specific medical device subject to review.
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 the Safety and Performance Based Pathway, a special approach that could be used to place medical devices on the US market. The document is intended to provide additional clarifications and recommendations to be considered by medical device manufacturers concerning the applicable regulatory requirements. However, the provisions of the guidance are non-binding in their legal nature, hence, the document does neither introduce new rules nor impose new obligations. Moreover, an alternative approach could be applied, provided such an approach complies with the respective regulatory requirements.
Table of Contents
Eligible Devices
First of all, the guidance outlines the specific criteria to be considered when determining the eligibility of a medical device for the framework in terms of intended use and technological characteristics. In particular, the document provides eligible product codes, as well as intended uses and indications for use. Furthermore, the authority mentions that the list of eligible device types is available on its official website. According to the guidance, when applying, an interested party should include references to similar medical devices already placed on the market (predicate devices) for which a substantial equivalence could be established about the intended use and technological characteristics. In particular, the authority states that clarifying the set of devices for which the performance criteria are appropriate in guidance and having submitters identify a predicate of the same device type will help ensure that a new device that utilizes this program has (1) the same intended use as and (2) technological characteristics that do not raise different questions of safety and effectiveness from the predicate device. In case the applicant has doubts regarding the eligibility of its device for the Safety and Performance Based Pathway, it should contact the authority, since the Agency expects it will manage to provide such advice without the need to undertake a complete review of the data related to the product, provided that the device in question complies with the general requirements set forth under this framework. At the same time, the authority is entitled to request additional data, should such data be reasonably necessary to complete such determination.
Performance Criteria
To assist medical device manufacturers and other parties involved, the authority will timely update the list of eligible device types, respective guidance documents, and also the applicable testing methods up-to-date. The guidance also contains references to the FDA-recognised voluntary consensus standards the manufacturers may use when demonstrating compliance with the corresponding regulatory requirements. The authority also explicitly mentions that performance criteria in FDA-recognised consensus standards that have not been identified in FDA guidance for use in the Safety and Performance Based Pathway should not be used in this program. Based on the applicable standards, as well as special controls and other information available, the authority will determine specific performance criteria to be used. FDA will ensure that these criteria represent performance levels that are at least equivalent to the performance of legally marketed devices of the type to which they apply. The authority also mentions that in case of any discrepancies, the determination it will make will be final and binding for the parties involved. As it was stated before, other special frameworks, such as Traditional, Special, and Abbreviated 510(k) are still used when placing medical devices on the market.
Data Review
The FDA further describes the approach it will apply when reviewing the data related to the medical device in question. In particular, the guidance outlines the scope of data the applicant should submit for the FDA to be able to make an informed decision. According to the guidance, to support an FDA finding of substantial equivalence through this program, FDA expects a submitter to demonstrate that the device meets the FDA-identified performance criteria by submitting a Declaration of Conformity to an FDA-recognized consensus standard, testing protocols, a results in summary, and/or underlying data (i.e., complete test report), as appropriate. In the case the medical device manufacturer applying for the marketing approval follows the methods prescribed by the respective standard, it would be sufficient to provide a Declaration of Conformity. However, in certain cases, the authority may require specific testing methods to be used, and then the applicant would also have to provide a results summary. When FDA establishes performance criteria and recommends or specifies testing methodologies that are not in existing FDA-recognized consensus standards, and the submitter uses such methods, the submitter should also submit a testing protocol describing the test methodology and a results summary demonstrating that the FDA-identified performance criteria have been met. Should the submitter apply a methodology other than recommended by the FDA or specified in the respective standards, a complete test report should be submitted. At the same time, in all cases, the authority reserves the right to support the underlying data the reports and summaries are based on. Should it be identified that the data submitted by the applicant does not confirm that the product subject to review complies with the respective criteria, a substantial equivalence would not be established. However, it would still be possible to apply for marketing approval under other frameworks.
Thus, depending on the applicable performance criteria and testing methodology, the submitter would have to provide one of the sets of documents listed below:
- Declaration of Conformity;
- Results Summary and Declaration of Conformity;
- Results Summary and Testing Protocol;
- Complete Test Report.
Modifications to the List of Eligible Devices
As it was mentioned before, the regulating authority is entitled to modify the list of device types eligible for the Safety and Performance Based Pathway. The current version will be at all times available via the official website together with the respective guidance documents and recommended testing methods. The guidance document, as well as additional information regarding the framework, would be subject to periodic review to reflect the changes to the respective legislation. For instance, in certain cases, some of the device types would be removed from the list or subject to additional requirements.
In summary, the present FDA guidance describes the specific criteria to be applied when determining whether the medical device in question is eligible for the Safety and Performance Based Pathway. The document highlights the key points to be considered and also outlines the scope of documentation to be submitted to substantiate the application.
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