The article describes in detail the aspects related to the use applicability of the electronic submission framework in case of innovative products to be placed on the market.
Table of content
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to electronic submission templates for medical device De Novo requests.
Once finalised, the guidance will provide an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance thereto.
At the same time, it is important to mention that FDA guidance documents are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing regulatory framework and has been agreed with the authority in advance.
Regulatory Background
The FDA has issued this guidance document to guide submitters of De Novo requests to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).
The intent is to familiarize them with the resources and content supporting De Novo’s electronic submissions to the FDA. By doing this, the FDA intends to:
- Improve submission consistency by using electronic submission templates.
- Enhance the review process’s efficiency.
- Comply with the mandate of section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was amended by section 207 of the FDA Reauthorization Act of 2017 (FDARA).
This mandates the FDA to specify standards for electronic format submissions, provide a timetable for establishing these standards, and set criteria for waivers and exemptions.
The FDA has another guidance document referred to as “745A(b) device parent guidance”.
This document details the process for developing templates to assist in the preparation, submission, and review of regulatory submissions for medical devices exclusively in electronic format.
According to section 745A(b)(3) of the FD&C Act, Congress has provided FDA with the authority to define the requirements for electronic submissions.
This document covers the FDA’s interpretation of the electronic submissions requirement. The guidance emphasizes that while some provisions will be binding, others will merely serve as recommendations.
The FD&C Act, as modified by section 207 of FDARA, mandates electronic submissions for specific devices and supplements, with stipulated timelines.
The FDA has also committed to developing electronic submission templates through the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter.
This endeavour aims to boost submission consistency and improve the review process’s efficiency.
In February 2020, CDRH initiated a pilot program for the electronic Submission Template And Resource (eSTAR) electronic submission template. By January 2022, this template was expanded to facilitate De Novo requests.
The Center for Biologics Evaluation and Research (CBER) began using eSTAR for 510(k)s in June 2022. During a specified transition period,
De Novo electronic submissions can be made voluntarily using the eSTAR template.
This guidance details the technical standards associated with the preparation of the electronic submission template for De Novo classification requests.
It aims to facilitate the collection and assembly of the necessary components of a “complete” submission. While this guidance doesn’t get into the details related to the user interface and intricate content of the eSTAR, it establishes the De Novo electronic format in compliance with section 745(A)(b)(3) of the FD&C Act.
The FDA plans to introduce new eSTAR versions as relevant policies evolve and continue to gather and consider public feedback.
Terms and Definitions
In order to assist the parties involved with interpreting the provisions of the applicable legislation and following the requirements set forth therein, the document explains the key terms and concepts used in this respect, including:
- eCopy: A duplicate device submission in electronic format replicating the previously required paper submission to the FDA.
- Electronic Submission (eSubmission): The submission package generated by an electronic submission template containing the data of a ‘complete’ submission.
- eSTAR (electronic Submission Template And Resource): A specific electronic submission template within a structured dynamic PDF guiding a user in constructing an eSubmission. It is currently the only available template for De Novo requests as eSubmissions.
- Electronic submission template: A tool for the industry that guides through the relevant contents and components for the respective premarket submission type and device. It enhances submission preparation while ensuring consistency, quality, and efficiency in the premarket review process.
- Structured data: Data and content captured in fields, dropdown boxes, checkboxes, etc., within the electronic submission template.
- Unstructured data: Data and content are submitted as attachments to the electronic submission template.
Conclusion
In summary, the present guidance provides a comprehensive overview of the FDA’s efforts in introducing and promoting electronic submissions, specifically for De Novo requests.
The document also highlights the key points to be taken into consideration by medical device manufacturers and other parties involved.
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