The article highlights the key points associated with the electronic submissions template described by the US 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 electronic submission templates for medical device submissions under 510(k) framework.
The document provides 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, most of the provisions of the guidance 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 legislation and has been agreed with the authority in advance.
The present guidance aims to inform those submitting to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) about the resources available for these electronic submissions.
The document is part of the FDA’s commitment to developing electronic submission templates that will enhance the uniformity of submissions and streamline the review process.
The objective of this guidance is to ensure that there is a consistent and efficient method of submission, in line with the FDA’s mandate as outlined in section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
This mandate, amended by the FDA Reauthorization Act of 2017, emphasizes the need for setting standards for electronic submissions, establishing a timeline for these standards, and detailing the criteria for possible waivers and exemptions.
Additionally, the FDA’s guidance document titled “Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act” provides additional details on the process of creating templates to aid in the electronic submission of regulatory submissions for medical devices.
As per this guidance, the FDA intends to introduce the prerequisites of section 745A(b)(3) of the FD&C Act through individual guidance documents that specify the formats for particular submissions and their respective timelines.
Furthermore, section 745A(b)(3) of the FD&C Act grants the FDA the authority to stipulate electronic submission requirements through guidance.
This document, therefore, provides clarity on the FDA’s interpretation of the requirement for electronic submissions exclusively in electronic format.
While this guidance offers certain binding provisions, it also has nonbinding elements that are intended to clarify current statutory requirements.
Electronic Submissions: Key Points
Historically, section 745A(b) of the FD&C Act, which was amended by section 207 of FDARA, requires that specific device submissions be made electronically in a format specified by the FDA.
In line with this, the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter established the FDA’s commitment to the development of electronic submission templates to foster submission consistency and improve the efficiency of the review process.
In September 2018, the FDA initiated the “Quality in 510(k) Review Program Pilot” for the electronic submission of certain 510(k)s using the eSubmitter template.
However, this pilot program, along with the use of the eSubmitter electronic submission template, concluded in May 2021.
Subsequently, in February 2020, CDRH began piloting the electronic Submission Template And Resource (eSTAR) electronic submission template. CBER commenced its pilot of eSTAR in June 2022.
The eSTAR was developed based on experiences with the eSubmitter software and offers a range of benefits such as automation, content structuring, and more
It is important to mention that eSTAR is currently the sole electronic submission template available for 510(k) electronic submissions.
This guidance also elaborates on the technical standards associated with the preparation of the electronic submission template for 510(k)s, to ensure a complete and organized submission.
While the guidance does not go into specifics about the eSTAR’s user interface, it outlines the basics for the 510(k) electronic format, ensuring compliance with section 745(A)(b)(3) of the FD&C Act.
As policies evolve, the FDA plans to roll out newer versions of eSTAR, and there is an ongoing initiative to gather and assess public comments and stakeholder feedback.
Terms and Definitions
The guidance also provides definitions of the most important terms and concepts used in the context of the guidance including, inter alia, the following ones:
- eCopy: An electronic copy is a duplicate device submission in electronic format of the previously required paper copy submission sent to the FDA. The authority additionally emphasizes that it is not an electronic submission.
- eSubmitter: A freely available FDA software program that contains electronic submission templates, including the eSubmitter electronic submission template that was available for preparing 510(k) eSubmissions from September 2018, through May 2021, and is no longer available for use to prepare 510(k) submissions.
- eSTAR (electronic Submission Template And Resource): An electronic submission template built within a structured dynamic PDF that guides a user through the construction of an eSubmission.
As it was mentioned before, eSTAR is the only type of electronic submission template that is currently available to facilitate the preparation of 510(k) submissions as eSubmissions. It is also important to mention that “eSTAR” is often used when referring to the respective electronic submissions.
- Structured Data: Data and content that are captured in the fields, dropdown boxes, checkboxes, etc., within the electronic submission template.
- Unstructured Data: Data and content that are submitted as attachments to the electronic submission template.
In summary, the present FDA guidance provides an overview of the applicable regulatory requirements associated with electronic submissions. The document describes in detail the existing submission formats and highlights the key points to be taken into consideration by the interested parties.
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