Structure of the eSTAR

1、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.

2、Cover Letter / Letters of Reference

Attach a cover letter and any documents that refer to other submissions.

3、Submitter Information

Information on submitter and correspondent, if applicable, consistent with content from current Form FDA 3514, Sections B and C.

4、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submission, such as submission numbers for a prior not substantially equivalent (NSE) determination, prior deleted or withdrawn 510(k), Q-Submission, Investigational Device Exemption (IDE) application, premarket approval (PMA) application, humanitarian device exemption (HDE)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.

5、Consensus Standards

Identification of voluntary consensus standard(s) used, if applicable. This includes both FDA-recognized and non-recognized consensus standards.

6、Device Description

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)].

7、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.32

8、Classification

Identification of the classification regulation number that seems most appropriate for the subject device, as applicable

9、Predicates and Substantial Equivalence34

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)].”

10、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

11、Labeling

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.”

12、Reprocessing

Information for assessing the reprocessing validation and labeling, if applicable. See “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

13、Sterility

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

14、Shelf Life

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

15、Biocompatibility

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.’”

16、Software/Firmware

Submission of applicable software documentation, if applicable. See “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

17、Cybersecurity/Interoperability

Submission of applicable information regarding the assessment of cybersecurity, if applicable. See “Content for Premarket Submissions for Management of Cybersecurity in Medical Devices”44and “Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices

18、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

19、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.”

20、References

Inclusion of any literature references, if applicable

21、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,49and a 510(k) Summary50or statement

22、Amendment/Additional Information (AI) response

Inclusion of responses to Additional Information requests