March 23, 2023
As a medical device manufacturer, getting your product to market requires navigating through various regulatory hurdles. One of the most crucial steps is obtaining FDA clearance through the 510(k) notification process, so you can market your device in the US. However, this can be a daunting task without understanding all the 510(k) requirements. One of the latest requirements for the 510(k) process is use of the FDA's Electronic Submission Template and Resource (eSTAR) template, which will be required for all 510(k) Notifications starting October 1, 2023. This blog will describe how to effectively utilize the FDA's eSTAR template for your submission. We'll dive into everything you need to know about using the FDA 510(k) eSTAR template so that you can get your product cleared quickly and efficiently.
Introduction to the FDA 510(k)
The FDA 510(k) is a regulatory pathway for medical devices that are "substantially equivalent" to devices already on the market. Manufacturers must submit a premarket notification, or 510(k), to the FDA showing that their device is as safe and effective as a similar, legally marketed device.
The FDA 510(k) eSTAR template is an online submission tool that can be used to streamline the 510(k) notification process. This template guides users through each section of the submission, providing instructions and examples. It can be used voluntarily for 510(k) Notifications and De Novo Classification requests at the time of this writing, but will become required for all 510(k) Notifications starting October 1, 2023.
The FDA 510(k) eSTAR template is a valuable tool for manufacturers seeking to market their medical devices in the United States. By following the instructions and examples provided in the template, manufacturers can ensure that their 510(k) notifications are complete and accurate, helping to expedite the review process.
Overview of the 510(k) eSTAR Template
The FDA's 510(k) eSTAR template is a powerful tool that can help you streamline the process of submitting a 510(k) notification. The template provides a standard format for your 510(k) submission; it also allows you to electronically submit your notification to the FDA. The eSTAR template is an electronic submission template built within a structured dynamic PDF that guides a user through construction of an eSubmission. eSTAR is the only type of electronic submission template that is currently available to facilitate the preparation of a 510(k) submission.
The eSTAR template is divided into multiple sections that mirror those found in a 510(k) Notification. Each section has specific instructions that must be followed in order to complete the section. These sections can be found in the FDA eSTAR Guidance Document and are listed below:
Submission Type: Identification of key information that may be useful to FDA in the initial processing and review of the 510(k) submission, including content from current Form FDA 3514, Section A.
Cover Letter / Letters of Reference: Attach a cover letter and any documents that refer to other submissions.
Submitter Information: Information on submitter and correspondent, if applicable, consistent with content from current Form FDA 3514, Sections B and C.
Pre-Submission Correspondence & Previous Regulator Interaction: Information on prior submissions for the same device included in the current submission, such as submission numbers for a prior not substantially equivalent (NSE) determination, prior deleted or withdrawn 510(k), Q-Submission, Investigational Device Exemption (IDE) application, premarket approval (PMA) application, humanitarian device exemption (HDE) application, or De Novo classification request.
Consensus Standards: Identification of voluntary consensus standard(s) used, if applicable. This includes both FDA-recognized and non-recognized consensus standards.
Device description: In this section, you will need to provide a detailed description of your device, including its intended use, indications for use, components, materials, size, dimensions, weight, and performance specifications.
Proposed Indications for Use: Identification of the proposed indications for use of the device. The term indications for use, as defined in 21 CFR 814.20(b)(3)(i), describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.
Classification: Identification of the classification regulation number that seems most appropriate for the subject device.
Predicates and Substantial Equivalence: Identification of a predicate device. The submission should include a comparison of the predicate and subject device and a discussion why any differences between the subject and predicate do not impact safety and effectiveness.
Design / Special Controls, Risks to Health and Mitigation Measures: Applicable to Special 510(k) submissions only. Identification of the device changes and the risk analysis method(s) used to assess the impact of the change(s) on the device and the results of the analysis.
Labeling: The labeling section requires that you submit all of the labeling for your device, including the instructions for use (IFU). Submission of proposed labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e).
Reprocessing: Information for assessing the reprocessing validation and labeling, if applicable. See Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Sterility: Information on sterility and validation methods. See Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Shelf Life: Summary of methods used to establish that device performance is maintained for the entirety of the proposed shelf life.
Biocompatibility: Information on the biocompatibility assessment of patient contacting materials. See Use of International Standard ISO 10993-1 Biological Evaluation of medical devices – Part 1: Evaluation and testing withing a risk management process.
Software/Firmware: Submission of applicable software documentation. See Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Cybersecurity/Interoperability: Submission of applicable information regarding the assessment of cybersecurity. See Content of Premarket Submissions for Management of Cybersecurity in Medical Devices and Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
Electromagnetic Compatibility (EMC), Electrical, Mechanical, Wireless and Thermal Safety: Submission of the EMC, Electrical, Mechanical, Wireless and Thermal Safety testing for your device or summarize why testing is not needed. See Electromagnetic Compatibility (EMC) of Medical Devices
Performance Testing: For non-in vitro diagnostic devices: Provide information on the non-clinical and clinical test reports submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence. See Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.
References: Inclusion of any literature references, if applicable.
Administrative Documentation: Inclusion of additional administrative forms applicable to the submission, including but not limited to a general summary of submission/executive summary (recommended), a Truthful and Accuracy Statement, and a 510(k) Summary or statement
Benefits of Utilizing the eSTAR Template
The eSTAR template is a great way to streamline the process of submitting a 510(k) notification to the FDA. This template provides a standardized format for you to follow, which can help ensure that your notification is complete and accurate. In addition, using the eSTAR template can help save you time and effort in preparing your notification.
Utilizing the eSTAR template helps ensure that you are in compliance with FDA regulations for 510(k) notifications.
When is the eSTAR Template Required?
Starting October 1, 2023, all 510(k) Notifications unless exempted must be submitted as electronic submissions using eSTAR.
Best Practices for Using the eSTAR Template
The eSTAR template is available on the FDA website and provides guidance on what information should be included in each section of the 510(k) submission. Best practices for using the eSTAR template include:
1. Reviewing the instructions and requirements for 510(k) submissions on the FDA website before beginning to fill out the eSTAR template. This will ensure that you understand what information is required in each section, and will help you avoid any mistakes that could delay or prevent your submission from being accepted.
2. Carefully filling out all required information in the eSTAR template. Incomplete or inaccurate information can delay or prevent your submission from being accepted, so it is important to take care when completing each section.
3. Organizing your supporting documentation in a way that makes it easy to find and reference when completing the eSTAR template. This will save time and frustration when trying to locate specific documents during the submission process.
4. Use PDFs as attachments to the eSTAR template. Each section requires an attachment to be marked complete. One file cannot be added multiple times, but the file can be renamed and added in multiple sections.
5. The attachments are placed in alphabetical order on the navigation bar. To ensure the attachment files remain in the correct order, use numbers in the file names, similar to the 510(k) section numbers.
6. Submitting your completed eSTAR template and supporting documentation to the FDA for review well in advance of your intended market launch date. This will allow time for any necessary revisions to be made, and will help ensure that your device is able to hit the market on schedule.
Common Mistakes to Avoid when Using the eSTAR Template
1. One of the most common mistakes when using the eSTAR template is not including all of the required information. Make sure to include all pertinent information in each section in order to avoid delays or rejection from the FDA.
2. Another common mistake is not following the proper format. The eSTAR template must be completed in a specific format in order for it to be accepted. Be sure to review the formatting requirements before beginning your submission.
3. Finally, make sure that you have reviewed and proofread your submission before sending it off to the FDA. Any errors or omissions could result in delays or rejection of your notification.
The FDA 510(k) eSTAR Template is a valuable resource for medical device manufacturers who wish to submit a 510(k) notification. By utilizing the template, you can ensure that your submission meets all of the requirements set forth by the FDA and will have a much better chance of being swiftly approved. You should also take advantage of additional information included in the FDA guidance documents when preparing your 510(k). For additional regulatory support completing your 510(k) Notification in eSTAR format, reach out to Folio Consulting Group, LLC.
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