The present article provides an overview of the applicable regulatory policy introduced by the authority.
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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 replacement reagents and instrument family policy for in vitro diagnostic (IVD) medical devices. 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 in order to ensure compliance thereto. At the same time, it is important to mention that guidance documents issued by the US FDA are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, 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.
Regulatory Background
First of all, the authority emphasizes the importance of ensuring the wide availability of in vitro diagnostic medical devices for laboratory testing. The purpose of the present guidance is to ensure consistency in the application of the respective approach by all the parties involved. In particular, the scope of the guidance covers the following aspects:
- Manufacturer’s preliminary considerations for determining whether this guidance is applicable;
- The Replacement Reagent Policy;
- The Instrument Family Policy;
- Examples;
- Labeling;
- Clinical Laboratory Improvement Amendments (CLIA) categorization when the manufacturer determines, taking into account the considerations described in this guidance, that a 510(k) is not needed.
The guidance also contains flowcharts illustrating the approach to be applied when determining the regulatory nature of a medical device subject to review. However, the authority mentions that examples are provided for demonstration purposes only, and in no event, should be considered exhaustive, so the specific approach should be determined on a case-by-case basis.
The scope of the guidance covers the aspects related to in vitro diagnostic test systems allowed for marketing and use in the US and comprised of a cleared assay that is run on an automated laboratory instrument specified by the assay manufacturer. Specifically, it addresses a manufacturer’s application of an assay that was previously cleared for use based on performance characteristics when used with a specified instrument to an additional instrument previously cleared or a member of an instrument family from which another member has been previously cleared.
At the same time, there are certain aspects falling outside the scope of the present guidance, for instance:
- Changes to IVD devices other than assay application;
- Regulatory requirements for Class III medical devices;
- Products intended to be used in the context of blood banking practices;
- Products intended for prescription or over-the-counter (OTC) home use.
The authority also mentions that the present guidance is not intended to supersede device-specific guidance documents issued earlier by the FDA but rather to supplement them in terms of additional considerations.
The approach described in the document is based on the information available to the authority with respect to the use of cleared test systems. Should medical device manufacturers have any concerns or additional questions, the authority encourages them to get in touch in order to get additional clarifications. Apart from that, the pre-submission process could be used to obtain additional feedback before submitting an application under the 510(k) pathway, especially in the case of products utilizing novel technologies for which there is no sufficient performance data in place.
The document is intended to address a manufacturer’s application of an assay that was previously cleared for use based on performance characteristics when used with a specified instrument to an additional instrument previously cleared or a member of an instrument family from which another member has been previously cleared.
Replacement Reagent Policy: Key Points
Under the general rule, 510(k) clearance for test systems is based on assay performance characteristics demonstrated with an instrument (or instruments) specified by the assay manufacturer. After the initial clearance is granted, the manufacturer may expand the scope of applicability of the assay to additional instruments that have already been reviewed as a part of a test system. The document further uses the term “replacement reagents” to describe such assays. In most cases, the same manufacturer manufactures both assays and instruments subject to review. At the same time, the approach described herein could also be applied in the case of an assay and instrument manufactured by different manufacturers. According to the guidance, the assay manufacturer should assess the capabilities and performance of the new combination of assay and instrument under the quality system requirements for the assay to ensure acceptable performance of the test system. Apart from this, the manufacturer of an assay in question will also be responsible for ensuring that the test system still meets design specifications after being modified. Should several manufacturers be involved, the authority encourages them to be in touch to make sure the newly introduced modifications will not affect the overall performance of the test system in question.
According to the guidance, a manufacturer intended to introduce modifications described herein should determine whether a new 510(k) will be required. For this purpose, the manufacturer should:
- Confirm that the assay was previously cleared and the instrument was either previously cleared or is an instrument family member of an instrument that was previously cleared;
- Apply the considerations described [in the present guidance].
Should upon completion of the above steps, the manufacturer decide that a new 510(k) is not required, the decision-making process, as well as the changes themselves, should be duly documented.
In summary, the present FDA guidance describes the approach to be applied with respect to specific changes to in vitro diagnostic medical devices. The document outlines the scope of applicability of the regulatory framework and highlights the key points to be taken into consideration by the manufacturer.
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