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Unlocking FDA eSTAR: Streamlining Medical Device Approvals with the Electronic Submission Template
The Food and Drug Administration (FDA) plays a crucial role in regulating medical devices in the US and ensuring their safety and effectiveness for public health. In recent years, the FDA has implemented various initiatives to streamline regulatory processes and enhance efficiency in reviewing medical device submissions. One such initiative is the FDA eSTAR program, designed to modernize and expedite the review process for certain medical device submissions.
What Is eSTAR by FDA?
The FDA eSTAR program, which stands for electronic Submission Template and Resource, is an electronic submission platform introduced by the FDA to facilitate the submission and review of select medical device applications. It aims to improve the efficiency, consistency, and transparency of the review process by providing a standardized electronic platform for submitting relevant documentation and information.
eSTAR is required as of October 2023 for all medical device 510(k) submissions, unless exempted, to the Center for Devices and Radiological Health (CDRH) or to the Center for Biologics Evaluation and Research (CBER). This requirement includes 510(k) combination products and Dual 510(k)/CLIA Waiver IVD submissions. eSTAR is voluntary for medical device De Novo submissions to CDRH or CBER. eSTAR is also voluntary for medical device PMA and Pre-Submissions to CDRH.
What are eSTAR Requirements?
To participate in the eSTAR program, medical device manufacturers and sponsors must adhere to specific requirements outlined by the FDA. These requirements include:
Electronic Submission: One of the fundamental requirements of the eSTAR program is the submission of all relevant documentation and information electronically through the FDA's designated eSTAR platform. Electronic submissions ensures consistency, accuracy, and efficiency in the review process compared to traditional paper-based submissions.
Use of Templates: The FDA provides predefined templates within the eSTAR platform for organizing and presenting essential information related to medical device submissions. These templates cover various aspects of the submission, including device descriptions, manufacturing processes, clinical data, risk assessments, and labeling information. Adherence to these templates helps standardize the format and presentation of submission materials, making it easier for reviewers to assess the content effectively.
Compliance with Regulatory Standards: Medical device submissions through the eSTAR program must comply with applicable regulatory standards and guidelines set forth by the FDA. This includes adherence to regulatory requirements outlined in the Code of Federal Regulations (CFR), relevant guidance documents, and industry standards such as ISO 13485 (Quality Management Systems for Medical Devices) and ISO 14971 (Risk Management for Medical Devices). Ensuring compliance with regulatory standards helps maintain the integrity, quality, and safety of medical devices undergoing review.
Data Integrity and Security: Applicants participating in the eSTAR program are responsible for maintaining the integrity and security of the data submitted through the platform. This includes safeguarding sensitive information, protecting against unauthorized access or disclosure, and ensuring the accuracy and reliability of submitted data. Implementation of robust data management and security measures is essential to prevent data breaches, maintain confidentiality, and uphold regulatory compliance standards.
Submission Validation: Prior to submission, applicants are encouraged to perform thorough validation checks to ensure that their submission documents meet the required formatting, content, and quality standards specified by the FDA. The eSTAR platform may also conduct automated validation checks to identify any potential errors or discrepancies in the submitted documents. Addressing validation issues proactively helps minimize delays and ensures smooth processing of submissions during the review phase.
How to submit eSTAR ?
Submitting a medical device application through the FDA's eSTAR program involves several steps:
Registration: Before submitting through eSTAR, medical device manufacturers, sponsors, or their authorized representatives must register with the FDA's electronic submission system. Registration typically involves providing necessary information about the organization or individual, including contact details and user credentials.
Accessing the eSTAR Platform: Once registered, users gain access to the eSTAR platform, where they can begin the submission process. The eSTAR platform provides a user-friendly interface for uploading submission documents and navigating the submission workflow.
Preparation of Submission Documents: Before initiating the submission process, applicants should ensure that all required documentation and information are prepared according to the FDA's guidelines and requirements. This may involve organizing submission materials using predefined templates provided by the FDA and compiling relevant data, such as device descriptions, manufacturing processes, clinical data, risk assessments, and labeling information.
Uploading Documents: Within the eSTAR platform, users can upload their submission documents and supporting materials in the specified file formats. The platform typically supports various file formats commonly used for electronic documents, such as PDF, Word, Excel, and XML. Users should carefully review document naming conventions and file size limitations specified by the FDA to ensure successful upload and processing of submission materials. Users also do not need to include an Indications for Use page, a Premarket Review Submission Cover Sheet, or a Declaration of Conformity, as these documents are incorporated into the eSTAR PDF.
Submission Validation: After uploading the submission documents, the eSTAR platform may perform automated validation checks to ensure compliance with formatting requirements, data integrity standards, and regulatory guidelines. Users should monitor the validation status and address any identified issues or errors promptly to prevent delays in the submission process.
Review and Confirmation: Once the submission documents pass the validation checks, users can review the submission package and confirm readiness for submission. It's essential to verify the completeness, accuracy, and consistency of the submission materials before finalizing the submission.
Submission Authorization: Before final submission, users may need to authorize the submission electronically by affirming their consent and compliance with regulatory requirements. This authorization step serves as a confirmation of the user's responsibility for the accuracy and integrity of the submitted data.
Submission Confirmation and Tracking: Upon successful submission, users receive confirmation from the FDA, along with a unique submission identifier or tracking number for reference. This identifier allows users to track the status of their submission, monitor review milestones, and communicate with FDA reviewers regarding the application's progress.
Post-Submission Activities: Following submission, applicants should remain responsive to requests for additional information or clarification from FDA reviewers. They may also engage in ongoing communication with the FDA to address any questions or concerns that arise during the review process.
What is the Review Timeline?
The review timeline for eSTAR submissions varies depending on the type and complexity of the medical device application. However, the FDA aims to expedite the review process for eSTAR submissions compared to traditional paper-based submissions. Typically, the FDA provides estimated review timelines and milestones to applicants, allowing them to track the progress of their submissions and anticipate feedback or requests for additional information.
After the FDA receives an eSTAR submission, given that an electronic submission properly prepared with an electronic submission template should represent a complete submission, eSTAR submissions are not anticipated to undergo a refuse to accept (RTA) process. However, the FDA intends to employ a virus scanning and technical screening process for an eSTAR.
If the eSTAR does not pass technical screening (i.e., an eSTAR is provided where none of the attachments to a question are relevant to the question, or if an inaccurate response is provided to any question), the submission may be put on an early Technical Screening hold for 180 days, until a complete replacement eSTAR is submitted.
If an eSTAR provided by mail is not complete when submitted, FDA will notify the submitter by email and identify the incomplete information, and the submission will be placed and remain on hold for 180 days or until a complete replacement eSTAR is submitted to the FDA.
For more information, see Electronic Submission Template for Medical Device 510(k) Submissions.
The remainder of a 510(k) review will be conducted according to the FDA guidance, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]," following the procedures identified in 21 CFR 807 subpart E.
A De Novo classification request will be reviewed according to 21 CFR part 860 subpart D, and as described in the FDA guidance, "De Novo Classification Process (Evaluation of Automatic Class III Designation)."
A PMA will be reviewed according to 21 CFR part 814.
In conclusion, the FDA eSTAR program represents a significant advancement in the regulatory review process for medical devices, offering a streamlined and standardized approach to submission and review. By leveraging electronic submission platforms like eSTAR, manufacturers and sponsors can enhance efficiency, reduce administrative burdens, and accelerate market access for innovative medical technologies.