The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance describing the electronic submission template to be used for medical device 510(k) submissions. The document is intended to describe the regulatory approach recommended by the FDA. The authority encourages medical device manufacturers and other parties involved in operations with medical devices to provide their feedback and suggestions, which will be taken into consideration by the Agency when developing a final version.
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Once finalized, the document will provide additional clarifications and recommendations on the matter. The authority additionally emphasizes that the provisions of the FDA guidance documents are non-binding in their legal nature and are not intended to introduce new rules or requirements. Moreover, an alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements and has been approved by the authority in advance.
Regulatory Background
The present FDA guidance is intended to provide the parties interested in filing a 510(k) electronic submission for a medical device. In particular, the document highlights the most important aspects associated with the use of electronic format for 510(k) submissions in accordance with the applicable legislation. The authority also mentions that certain other matters associated with 510(k) submissions are addressed in the appropriate guidance documents issued separately. By virtue of this document, the regulating authority intends to specify in guidance the electronic submissions requirements by providing standards, criteria for waivers and exemptions, and a timetable for such submissions. Hence, the present FDA guidance provides additional clarifications regarding how the relevant provisions of the current legislation should be interpreted by the parties applying for marketing approval while using the electronic submission format. As mentioned, the provisions set forth herein are neither binding for the Agency nor for other parties involved. The applicant or entity interested in filing a 510(k) submission may contact the authority in advance in order to agree on the approach to be applied. However, once finalized, the present guidance will contain some binding provisions as well, in particular those containing references to the applicable regulatory requirements. Such provisions will be provided in a way that ensures their correct interpretation by the parties involved. Thus, the provisions of the guidance should be considered non-binding unless otherwise explicitly stated by the FDA.
History of Development
First, the Agency states that the current legislation requires that pre-submissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of the Food, Drugs and Cosmetics (FD&C) Act or section 351 of the Public Health Service Act, and any supplements to such pre-submissions or submissions, including appeals of those submissions, be submitted in electronic format specified by the Food and Drug Administration beginning on such date as specified by FDA in final guidance.
It is also stated that the first step in the implementation of the electronic submissions was taken earlier in September 2018 when the regulating authority commenced the “Quality in 510(k) Review Program Pilot,” allowing interested parties to use eSubmitter for traditional and Abbreviated 510(k) pathways. The authority mentions that the eSubmitter template was developed by FDA as an optional free tool consisting of a collection of questions, text, logic, and prompts that guides a user through preparation of a 510(k) submission in electronic format. Using this tool, the applicant could form a complete submission in a fast and efficient manner. Then, later in February 2020, the eSTAR Pilot Program was launched. According to the present guidance, the main benefits of the eSTAR concept are the following:
- Automation (e.g., form construction, auto-filling);
- Content and structure that is complementary to CDRH internal review templates;
- Integration of multiple resources (e.g., guidances, databases);
- Guided construction for each submission section;
- Automatic verification; and
- Free for use.
The authority additionally emphasizes that eSTAR provides the use of general software instead of a proprietary one, which also simplifies its use for the applicants. In general, the improvements made represent a significant improvement in the effectiveness of the review when applying the eSTAR pathway. For instance, the structure of the submissions prepared in such a way will match the structure of internal templates applied when reviewing the submissions. By employing such an approach, the FDA facilitates the reviews of the submissions in order to improve the effectiveness of the regulatory procedures associated thereto.
Scope and Definitions
The scope of the present FDA guidance covers the most important aspects related to the use of the electronic submission format. In particular, the document describes the technical standards to be applied when filing the 510(k) submission in electronic format. The guidance contains important recommendations to be considered by the applicants when composing a submission in order to ensure its completeness, as well as the correct structure facilitating its further review by the FDA. Thus, the document outlines the elements to be included in 510(k) electronic submission and also describes the particular structure of the submission to be followed.
In order to assist medical device manufacturers and other parties involved in interpreting provisions of the applicable legislation, and also following the requirements provided therein, the guidance also contains the definitions of the most important terms and concepts used, including the following:
- eCopy (an electronic copy) – a submission created and submitted on a compact disc (CD), Digital Versatile Disc (DVD), or flash drive and mailed to FDA, and which is a duplicate of the previously required paper copy sent to FDA. The authority additionally emphasizes that the eCopy should not be construed as electronic submission.
- eSubmission (Electronic Submission) – a submission package produced by an electronic submission template that contains the data of a “complete” submission.
- eSTAR (electronic Submission Template And Resource) – an electronic submission template built within a structured dynamic PDF that guides a user through construction of an eSubmission.
Apart from those listed above, the document also provides definitions of such terms as “eSubmitter,” “Electronic submission template,” “Structured data,” “Unstructured data.”
In summary, the present FDA draft guidance dedicated to the 510(k) electronic submissions for medical devices provides a brief overview of the applicable legislation, as well as the development of the new approach in general. The document also pays special attention to the applicable regulatory requirements and terminology used.
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