An Overview of 510(k) Electronic Submission Guidance for FDA 510(k) Submissions
Nov 11 2022
On October 3, 2022 the FDA announced that sending electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions are now available online through the CDRH Customer Collaboration Portal.
This article provides an overview of the new 510(k) electronic submission guidance document that the FDA released in September 2022.
Q1: What is eCopy?
A1: According to the FDA, an electronic copy is a duplicate device submission in electronic format of the previously required paper copy submission sent to FDA. An electronic copy is not considered to be an electronic submission (eSubmission).
Q2: What is eSTAR (electronic Submission Template And Resource)?
A2: It 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 that is currently available to facilitate the preparation of 510(k) submissions as eSubmissions. To simplify, the electronic submission created with this electronic submission template is often referred to as an eSTAR.
Q3: What is the deadline for compliance with the guidance?
A3: The FDA informed that using the eSTAR template and compliance with the eSTAR guidance is not mandatory until October 1, 2023. Thus, after FY 2023, all 510(k) submissions must be submitted as an eSTAR submission instead of using traditional 510(k) submission format.
Q4: What are the new sections for a 510(k) submission?
A4: Unlike the guidance of a traditional 510(k) that outlines the 20 sections, the new 510(k) electronic submission guidance has no numbering for the sections of the eSTAR template. Also, there are 22 sections instead of 20 sections. New sections include elements of the current FDA submission cover sheet (i.e., FDA Form 3514), and some sections in the 2019 guidance were eliminated, such as: "Class III Summary and Certification."
Q5: What is the structure of the current eSTAR 510(k) electronic submission template?
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.
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.
Identification of voluntary consensus standard(s) used, if applicable. This includes both FDA-recognized and nonrecognized consensus standards.
Identification of listing number if listed with FDA. Descriptive information for the device, including a description of the technological characteristics of the device including materials, design, energy source, and other device features, as defined in section 513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(A). Descriptive information also includes a description of the principle of operation for achieving the intended effect and the proposed conditions of use, such as surgical technique for implants; anatomical location of use; user interface; how the device interacts with other devices; and/or how the device interacts with the patient. Information on whether the device is intended to be marketed with accessories. Identification of any applicable device-specific guidance document(s) or special controls for the device type as provided in a special controls document (or alternative measures identified that provide at least an equivalent assurance of safety and effectiveness) or in a device-specific classification regulation, and/or performance standards. See “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].”
Proposed Indications for Use (Form FDA 3881)
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.
Identification of the classification regulation number that seems most appropriate for the subject device, as applicable.
Predicates and Substantial Equivalence
Identification of a predicate device (e.g., 510(k) number, De Novo number, reclassified PMA number, classification regulation reference, if exempt and limitations to exemption are exceeded, or statement that the predicate is a preamendments 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 [see section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)]. A reference device should also be included in the discussion, if applicable. See “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].”
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. Risk control measures to mitigate identified risks (e.g., labeling, verification). See “The Special 510(k) Program.”
Submission of proposed labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e). Generally, if the device is an in vitro diagnostic device, the labeling must also satisfy the requirements of 21 CFR 809.10. Additionally, the term “labeling” generally includes the device label, instructions for use, and any patient labeling. See “Guidance on Medical Device Patient Labeling.”
Information for assessing the reprocessing validation and labeling, if applicable. See “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”
Information on sterility and validation methods, if applicable. See “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.”
Summary of methods used to establish that device performance is maintained for the entirety of the proposed shelf-life41 (e.g., mechanical properties, coating integrity, pH, osmolality), if applicable.
Information on the biocompatibility assessment of patient contacting materials, if applicable. See “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.’”
Submission of applicable software documentation, if applicable. See “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”
Submission of applicable information regarding the assessment of cybersecurity, if applicable. See “Content for Premarket Submissions for Management of Cybersecurity in Medical Devices” and “Design Considerations and Premarket 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” and “Radio Frequency Wireless Technology in Medical Devices.”
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 NonClinical Bench Performance Testing Information in Premarket Submissions.” 48 For in vitro diagnostic devices: Provide analytical performance, comparison studies, reference range/expected values, and clinical study information.
Inclusion of any literature references, if applicable.
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.
Amendment/Additional Information (AI) response
Inclusion of responses to Additional Information requests.
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