From October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using eSTAR. eSTAR is an interactive PDF document designed for the preparation of a comprehensive medical device pre-market submission for the FDA's 510(k)-clearance process in the United States. Also, applicants can utilize the eSTAR when the FDA requests additional information on how to submit responses to requests for additional information. The aim of eSTAR is to improve the quality of submissions for various medical devices by ensuring that submitters provide complete and high-quality data for the FDA's pre-market review.
eSTAR submissions are not anticipated to undergo the Refuse to Accept (RTA) review process due to the use of automatic verification integrated with multiple resources (such as guidance & databases) and guided construction for each section in submission. By adopting an eSTAR format, submitters can be confident in the completeness of their submissions, enabling the FDA to conduct pre-market reviews more efficiently and ensuring timely access to safe and effective medical devices. This user template is available free of charge and can be voluntarily used by all medical device submitters for 510(k)s and De Novos submitted to the FDA. The US Health Authority recommends using Adobe Acrobat Pro or Foxit PDF Editor as an application for editing the eSTAR templates.
Where Can I Access and Submit eSTAR for Pre-market Submission?
One can access and use eSTAR for a medical device submission by following these steps:
- Download the eSTAR PDF template from the FDA website: eSTAR Program based on current eSTAR versions from the portal as Medical devices and In Vitro Diagnostic devices.
- Prepare the Submission: It ensures a standardized format, complete with prompts, questions, and guidance, enabling applicants to provide precise and comprehensive information.
- Register for an Account: Registration for an account in the CDRH Portal is open to all, allowing individuals to submit CDRH eSTAR or eCopy pre-market submissions conveniently online.
- Submit the Application: From October 1, 2023, all 510(k) submissions, except exempted ones, must be electronically submitted via eSTAR. Until that date, 510(k)s can be submitted through the CDRH Portal using either the eSTAR or eCopy format or via mail.
What Information is Required in an eSTAR Submission?
The eSTAR submission requires specific Regulatory information to be covered in the comprehensive medical device submission. An overview of the required information based on the available search results is mentioned below:
- eSTAR Template: Utilize the eSTAR interactive PDF form for preparing the pre-market submission, offering a standardized format for the Regulatory submissions.
- Complete and Accurate Information: Ensure the submission comprises precise and comprehensive details about the medical device, including its consensus standards, indication for use, predicate and substantial equivalence, labeling, sterility, shelf life, biocompatibility, Software/Firmware, Cybersecurity/Interoperability, Electromagnetic compatibility, Electrical, Mechanical, Wireless and Thermal Safety and performance testing (Bench testing, Animal and Clinical studies).
- No Additional Forms: Certain forms, like the Indications for Use page (Form FDA 3881), the Pre-market Review Submission Cover Sheet (Form FDA 3514), and autogenerated Declaration of Conformity, are already integrated into the eSTAR PDF, eliminating the need for separate submission.
Benefits of Using eSTAR for Medical Device Submissions:
The following are the benefits of using eSTAR for medical device submissions:
- Improves Transparency and Consistency: The eSTAR program enhances the transparency and consistency of the submission process by offering a standardized format, guided process, and improved completeness. This leads to increased efficiency in pre-market reviews by the FDA, ultimately promoting timely access to safe, effective, and high-quality medical devices.
- Enhances Incoming Quality of Submissions: eSTAR automatically creates relevant fields/sections that need to be addressed based on the answers to the initial questions. By encouraging submitters to provide comprehensive and high-quality data, it enhances the pre-market review process conducted by the FDA.
- Facilitates the Submission Process: The eSTAR program streamlines the submission process with an interactive PDF form, excluding the RTA review process, guiding applicants in preparing comprehensive medical device submissions. This efficiency can lead to reduced time and resource requirements for the clearance process.
- No e-Copy: eSTAR does not require e-Copy validation.
eSTAR marks a significant advancement in the Regulatory landscape for medical devices in the United States. This innovative digital platform streamlines the submission process and enhances efficiency, transparency, and collaboration between manufacturers and Regulatory Authorities. By replacing the traditional paper-based submissions with an electronic system, eSTAR accelerates the review process, ultimately expediting the time-to-market for safe and effective medical devices. To know more about eSTAR, reach out to our Regulatory experts today. Stay informed. Stay compliant.