The Food and Drug Administration (FDA), the US medical device regulating authority, has published a notice dedicated to the pilot program for a request for designation (RFD) and pre-request for designation (Pre-RFD) electronic submissions. The document was published in the course of public consultations procedure – the Agency is now waiting for the feedback and comments from industry representatives.

Scope of the Pilot Program

According to the official notice published in the Federal Register, the Office of Combination Products (OCP), a division of the FDA, announced the intent to initiate a new pilot program aimed at improvement of the RFD and Pre-RFD submission procedures. In particular, the OCP is going to introduce an electronic submission process. The pilot program would cover nine participants. As a result, the authority is expecting to collect necessary information and evaluate the actual effectiveness of the new approach. It is also important to mention that the period during which the industry representatives interested in participating should submit their applications to the OCP is quite short – only 10 days from the date the notice has been initially published.

Regulatory Background 

It is important to outline the role the OCP plays in processes and procedures related to placing medical devices on the market. The Office of Combination Products has been initially established in December 2002. From that time, the authority provides entities applying for the registration of medical devices (including manufacturers, their authorized representatives, importers, suppliers and other parties intended to place medical devices on the US market) with the consultations regarding the following aspects:

  • whether the medicinal product in question is subject to regulation under the appropriate framework as a drug, a medical device, a biological product, or a combination product,
  • which in particular division of the FDA should be responsible for the product: Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research, or Center for Biologics Evaluation and Research. 

Nowadays there are two ways the applicant may follow to obtain comments from OCP regarding its application, namely:

  1. To submit a Request for Designation to obtain a formal response which would contain a binding determination of the product in question, as well the assignment of the appropriate center. 
  2. To submit a Pre-Request for Designation. As a result, classification and assignment the feedback would contain would not be binding for the applicant. In most of the cases, Pre-RFD submission could be filed via email and provides the applicant with additional flexibility. 

OCP states that some of the submissions filed by the applicants actually do not contain important information that is necessary for the authority to assess the request. Thus, the main objective of the new pilot project is to introduce a new structure for both RFD and Pre-RFD submissions to improve the efficiency of the procedures associated thereto.

Request for Designation (RFD): Key Points

In accordance with the appropriate FDA guidance, the Agency recommends submitting Requests for Designation when the classification of a particular medicinal product in question or the Center the product should be assigned to is unclear. The entities responsible for the product shall submit a request when they will have all the information necessary for the Agency to make a correct determination. 

The FDA additionally emphasizes that the RFD should be submitted before filing any other applications related to the same medicinal product – this is important to avoid spending time on additional classification or assignment if it would be found necessary in the course of application review. 

If there are several questions related to classification issues, they should be submitted to the OCP separately. When preparing the RFD, the applicant may contact the Agency and ask about additional details or clarifications. In particular, OCP will provide the applicant with recommendations regarding the information and materials to be included in the scope of submission. If the applicant deems it necessary, it is also allowed to schedule a meeting with the OCP representatives. However, such a meeting is not mandatory – it is just an option an applicant may use. In this case, the applicant shall outline the most important issues to be discussed during the meeting. At the same time, according to the guidance, if the RFD is detailed enough, the information contained therein would be sufficient for the OCP to make its determination regarding the medicinal product in question. 

Besides the points described hereabove, the FDA guidance also highlights the following important aspects related to the Requests for Designation: 

  • The RFD submission process is regulated under 21 CFR Part 3. The aforementioned regulation covers the way the submission should be filed, as well as the information it should contain. 
  • The initial RFD review takes up to 5 business days. Within this time, OCP will check whether the submission is complete and contains all the information necessary to make a determination. Upon this, OCP will notify the applicant that the RFD submission has been successfully received, or will require to provide additional information necessary to assess the case. If no response has been received within 60 days from the date the RFD has been filed, the classification and assignment indicated by the applicant should be deemed correct and suitable. 
  • The applicant may withdraw its RFD submission anytime before the response from OCP has been received. 
  • If the applicant disagrees with the determination obtained, it may submit a request for reconsideration. Such a request should be filed within 15 days from the date the initial response from the regulating authority has been received. 
  • If the applicant possesses the information that falls outside the scope of the RFD submission, the applicant may submit a new RFD if it deems such information important to be considered by OCP. In this case, OCP will make its determination based on the latest submission received.

Request for Designation (RFD): Key Points

In accordance with the appropriate FDA guidance, the Agency recommends submitting Requests for Designation when the classification of a particular medicinal product in question or the Center the product should be assigned to is unclear. The entities responsible for the product shall submit a request when they will have all the information necessary for the Agency to make a correct determination. 

The FDA additionally emphasizes that the RFD should be submitted before filing any other applications related to the same medicinal product – this is important to avoid spending time on additional classification or assignment if it would be found necessary in the course of application review. 

If there are several questions related to classification issues, they should be submitted to the OCP separately. When preparing the RFD, the applicant may contact the Agency and ask about additional details or clarifications. In particular, OCP will provide the applicant with recommendations regarding the information and materials to be included in the scope of submission. If the applicant deems it necessary, it is also allowed to schedule a meeting with the OCP representatives. However, such a meeting is not mandatory – it is just an option an applicant may use. In this case, the applicant shall outline the most important issues to be discussed during the meeting. At the same time, according to the guidance, if the RFD is detailed enough, the information contained therein would be sufficient for the OCP to make its determination regarding the medicinal product in question. 

Besides the points described here above, the FDA guidance also highlights the following important aspects related to the Requests for Designation: 

  • The RFD submission process is regulated under 21 CFR Part 3. The aforementioned regulation covers the way the submission should be filed, as well as the information it should contain. 
  • The initial RFD review takes up to 5 business days. Within this time, OCP will check whether the submission is complete and contains all the information necessary to make a determination. Upon this, OCP will notify the applicant that the RFD submission has been successfully received, or will require to provide additional information necessary to assess the case. If no response has been received within 60 days from the date the RFD has been filed, the classification and assignment indicated by the applicant should be deemed correct and suitable. 
  • The applicant may withdraw its RFD submission anytime before the response from OCP has been received. 
  • If the applicant disagrees with the determination obtained, it may submit a request for reconsideration. Such a request should be filed within 15 days from the date the initial response from the regulating authority has been received. 
  • If the applicant possesses the information that falls outside the scope of the RFD submission, the applicant may submit a new RFD if it deems such information important to be considered by OCP. In this case, OCP will make its determination based on the latest submission received.

Application for Participation

In order to apply for participation in the RFD and Pre-RFD electronic submission pilot program, an interested entity shall submit its application via email. The application should contain:

  • Company name,
  • Contact person name,
  • Contact phone number,
  • Contact email address.

Besides these key elements, the applicants are encouraged to provide the information regarding its role (a sponsor or an authorized agent), and any RFDs or Pre-RFDS submitted by the same applicant previously. As it was already mentioned before, the number of applicants the FDA is limited.

How Can RegDesk Help?

RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.

Sources:

https://www.federalregister.gov/documents/2020/08/05/2020-17039/pilot-program-for-request-for-designation-and-pre-request-for-designation-electronic-submissions

https://www.fda.gov/media/80495/download


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