The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has developed a guidance document dedicated to Pre-Requests for Designation (Pre-RFD). The document describes the approach to be applied by manufacturers and other parties interested in placing medical devices on the market with regard to obtaining a preliminary assessment from the regulating authority. 

The present guidelines outline the scope of information to be provided by the interested party in the course of the submission and also address additional important aspects associated thereto. Due to its legal nature, the present FDA guidance does not introduce any rules or requirements itself but provides clarification and recommendations to be considered by the parties involved. The Agency additionally states that an alternative approach could be applied, provided that such an approach complies with the applicable regulatory requirements and has been approved by the authority in advance. 

Regulatory Background

According to the FDA guidance, the Pre-RFD procedure is intended to provide the manufacturer or another party interested in placing a medical device on the US market with informal, non-binding feedback from the Agency with regard to the regulatory status of the product in question in terms of its classification and applicable regulatory framework, as well as the particular FDA division responsible for further review of the submission. The FDA also mentions that aspects related to the formal Request for Designation or definitions of a combination and non-combination product actually fall outside the scope of the present guidance. 

As stated by the FDA, an interested party (an applicant, a sponsor) could receive feedback from the regulating authority in two ways:

– By submitting a formal Request for Designation (the feedback received in such a way would be final and binding for the applicant); or 

– By submitting a request for a preliminary jurisdictional assessment (in such a case, the feedback received would be non-binding).

Hence, the second approach provides the applicant with more flexibility. That is why this approach is widely used by medical device manufacturers and other parties before submitting their applications to the regulating authority for a formal review. The Agency acknowledges that in most cases, the aforementioned approach is preferable. 

In accordance with the applicable regulation, such non-binding feedback of the regulating authority with regard to classification of a product in question and also the FDA division responsible for further review could be received by the interested party in the course of the Pre-Request for Designation Program. The present FDA guidance is intended to highlight the most important aspects associated thereto, describe the approach to be applied by the regulating authority when reviewing the application, and also provide the applicant with additional clarification and recommendations. The document also describes applicable timeframes and the process itself. 

As mentioned before, the FDA guidance only provides non-binding recommendations. Moreover, in case of any discrepancies with the provisions of the applicable legislation, the latter should prevail. 

Pre-RFD in Brief

A Pre-Request for Designation is a written submission from an interested party requesting the Agency to provide a preliminary, non-binding assessment of the regulatory status of the product in question, or its classification as a drug, device, biological product, or combination product, and/or the determination of the particular division of the regulating authority which would be responsible for further review of the submission. The latter aspect is important for combination products consisting of products subject to regulation under different frameworks. 

Upon request, the FDA will provide the applicant with the non-binding preliminary classification and/or jurisdictional assessment requested by the device of the Pre-RFD on the basis of the information provided therein. The Agency states that the timeline should not exceed 60 calendar days from the day the information necessary to assess the request has been submitted to the authority. In the course of the review, the applicant may also contact the regulating authority to get additional clarification. Should the Agency fail to complete the review and provide the applicant with the determination within the timeline described above, the Agency will duly inform the applicant about the delay. 

The Agency additionally emphasizes that if the product in question is subject to significant changes after the submission of the Pre-RFD request, including changes to the indications for use or components, the feedback received by the applicant may no longer be applicable. Consequently, the applicant should stay in touch with the regulating authority and inform about any significant changes in a timely manner. 

In case of several products requiring such a classification/determination, the Pre-RFD requests should be submitted for each product subject to review separately. 

Despite its non-binding status, the Pre-RFD feedback provided by the regulating authority would still be based on a rigorous review of the information submitted by the applicant, and the appropriate FDA division would be involved if necessary. 

RFD and Pre-RFD

In order to assist medical device manufacturers and other parties involved, the FDA also provides a comparison between the formal Request for Designation and the Pre-Request for Designation described herein. In particular, the Agency outlines the similarities and differences of the aforementioned frameworks in order to provide the applicants with additional information to be considered when submitting the appropriate request.

1. In terms of similarities, both pathways require the applicant to submit basic information about the product in question, detailed enough to be sufficient for the FDA to perform the assessment. This information could include, inter alia, a description of the product, proposed use or indications, and a description of how the product achieves its intended therapeutic/diagnostic effects. In addition, a sponsor has the option to include additional information in a Pre-RFD that would be required for an RFD.

2. Differences between the two aforementioned pathways include the time necessary for the FDA to review the request and also the depth of regulatory analysis to be provided by the applicant. For instance, for an RFD, a sponsor must provide an analysis of a product`s classification, a primary mode of action (PMOA) analysis (if the RFD concerns combination product assignment), and a recommendation regarding the Agency Center assignment. Such information is optional in the Pre-RFD process. The Agency also mentions that the same primary mode of action analysis would be conducted irrespectively of whether the applicant would provide it in the course of the Pre-RFD.  

In summary, the present FDA guidance describes the main aspects related to the Pre-Request for Designation framework to be applied in order to obtain a non-binding preliminary classification of a product and/or determination of the Agency Center responsible for further review of the submission. The document provides additional information and clarification with regard to the procedure itself, as well as on the information to be provided by the applicant.

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