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eSTAR Program

    What is the eSTAR Program?

    The eSTAR Program, or electronic Submission Template And Resource, is a program developed by the Food and Drug Administration (FDA) to provide a standardized electronic submission template for medical device manufacturers. It is designed to streamline the FDA submission process for 510(k) submissions and other regulatory submissions in the medical device industry.

    The eSTAR Program is important for medical device manufacturers as it provides a standardized format for submitting information to the FDA, making the submission process more efficient and reducing the time and resources required for preparing and submitting regulatory documentation. By utilizing the eSTAR Program, manufacturers can ensure that their submissions are consistent, accurate, and in compliance with FDA requirements, ultimately helping to expedite the review and approval of their medical devices.

    Overall, the eSTAR Program plays a crucial role in simplifying the regulatory submission process for medical device manufacturers, allowing them to navigate the FDA submission process more effectively and bring their innovative products to market in a timelier manner.

    The History of eSTAR

    The eSTAR (Electronic Submission Template and Resource) was developed by the U.S. Food and Drug Administration (FDA) to streamline the electronic submission process for 510(k) filings, which are used to gain clearance for medical devices. The FDA has been working to improve the submission process for medical devices and launched a pilot program in 2017 to explore ways to enhance electronic submissions. This pilot program ultimately led to the creation of eSTAR, a template designed to standardize the format and content of electronic 510(k) submissions. The purpose of eSTAR is to facilitate the submission process for medical device manufacturers and improve the efficiency of the review process for the FDA’s Center for Devices and Radiological Health (CDRH).

    Key milestones in the history of eSTAR include the launch of the pilot program in 2017, the development of the eSTAR template, and its implementation as a resource for electronic 510(k) submissions. The template aims to provide clear guidance and improve the consistency and quality of medical device submissions to the FDA. Through the development and implementation of eSTAR, the FDA continues to advance its efforts to modernize and simplify the regulatory process for medical devices.

    Structure of the eSTAR Program

    The eSTAR Program has a structured and user-friendly process for submission, utilizing an interactive PDF form to guide applicants through the entire process. The program requires mandatory use of this form, which helps to streamline the submission process and ensure all necessary information is provided.

    The interactive PDF form is designed to be intuitive and easy to use, allowing applicants to input their information, upload required documents, and navigate through the submission process with ease. This helps to reduce errors and omissions and ensures that all necessary information is included.

    By utilizing an interactive PDF form, the eSTAR Program offers several benefits to applicants, including a more efficient and organized submission process, easy access to necessary forms and documents, and clear guidance throughout the process. This ultimately helps to enhance the overall experience for applicants and ensures that submissions are complete and accurate.

    Overall, the eSTAR Program’s use of an interactive PDF form demonstrates a structured and user-friendly approach to the submission process, providing clear guidance and streamlining the experience for applicants.

    eSTAR Eligibility Requirements

    To be eligible for the eSTAR pilot, medical device manufacturers must meet several specific criteria. The submission acceptance timeline for the pilot program is currently open for Health Canada, with submissions being accepted until December 31, 2022. For the FDA, the submission acceptance timeline is open until September 30, 2022.

    Excluded device types for the eSTAR pilot include in vitro diagnostic devices, combination products, and Class III devices that require clinical data. Additionally, devices intended for special populations such as pediatric or orphan indications are also excluded.

    Language requirements for the eSTAR pilot include submitting all documentation in English or French for Health Canada submissions and in English for FDA submissions.

    In summary, medical device manufacturers seeking to participate in the eSTAR pilot should ensure their devices meet the eligibility criteria, submit their applications within the specified timelines, and comply with the language requirements set forth by Health Canada and the FDA.

    Benefits of Participating in the eSTAR Program

    The eSTAR Program offers numerous benefits for participants, with a major advantage being the impact on review timelines. eSTAR submissions are processed more quickly, leading to improved efficiency and reduced turnaround time. By participating in eSTAR, individuals and organizations can streamline the submission process, reducing unnecessary documentation requirements and making the process more efficient.

    The key benefits of eSTAR submissions include faster review timelines, improved efficiency in the submission process, and a reduced turnaround time for feedback and decisions. By utilizing eSTAR, participants can experience a more streamlined and efficient review process, ultimately saving time and resources.

    In summary, participating in the eSTAR Program offers significant advantages, including faster submission processing, improved efficiency, and reduced documentation requirements. These benefits ultimately lead to shorter review timelines and quicker turnaround times, providing a more efficient and streamlined experience for all participants.

    Types of Products Covered by the eSTAR Program

    The eSTAR Program covers various types of products, including medical devices, diagnostics, and software. For 510(k) submissions, the eSTAR Program provides electronic submission capabilities for premarket notification of new devices. De Novo submissions, which are for new and innovative devices that do not have a predicate device, are also included in the eSTAR Program’s coverage. In development are potential submission types such as premarket approval (PMA) applications and investigational device exemptions (IDEs).

    The eSTAR Program is currently voluntary for 510(k) submissions, but it offers significant benefits, such as a streamlined submission process and improved efficiency in the review process. For De Novo submissions, it is also voluntary but provides the same advantages as for 510(k) submissions. In the future, there is the potential for the eSTAR Program to become required for all electronic regulatory submissions, resulting in a standardized and more efficient electronic submission process.

    Overall, the eSTAR Program aims to modernize the submission process for FDA submissions, making it more efficient and effective for all types of products.

    Regulatory Pathways for Submissions under eSTAR Program

    The eSTAR program offers several regulatory pathways for submissions to the FDA, including the 510(k) pathway for medical device clearance. The 510(k) pathway is used for demonstrating that a new medical device is substantially equivalent to a legally marketed device, thus streamlining the clearance process. The eSTAR program aims to expedite the FDA submission process by providing a digital platform for electronic submissions. This allows for more efficient review and communication between the FDA and the medical device industry. The program also requires certain criteria to be met in order to use it, such as adherence to FDA regulations and guidelines, as well as the submission of all necessary documentation and information. Overall, the eSTAR program offers a streamlined approach to FDA submissions, making it easier for medical device companies to navigate the regulatory process.

    What Information is Required in an eSTAR Submission?

    In an eSTAR submission for a medical device, specific regulatory information is required, including details about the device, consensus standards, indication for use, predicate and substantial equivalence, labeling, sterility, shelf life, biocompatibility, and safety and performance testing. The submission should include information on the device’s intended use, technological characteristics, and intended population, as well as any applicable consensus standards or recognized standards. It should also demonstrate substantial equivalence to a predicate device and provide comprehensive safety and performance testing data. Additionally, the submission should include details on labeling, sterility, shelf life, and biocompatibility.

    When submitting attachments, there are constraints regarding the size and count, as well as proper resolution and file formats for images and videos. The size and count of attachments should be in accordance with the eSTAR platform’s limitations. Images and videos should be in a high-resolution format and the appropriate file type to ensure clarity and readability.

    Is eSTAR voluntary?

    Yes, eSTAR (electronic Submission Template And Resources) is a voluntary electronic submission template that can be used for various types of medical device submissions, excluding 510(k) submissions. It offers a streamlined and user-friendly approach to preparing and submitting premarket submissions to the FDA.

    The eSTAR template includes features such as interactive tools, step-by-step guidance, and resources to help manufacturers organize and submit their premarket submissions. It can be accessed for use through the FDA’s electronic submission portal.

    Currently, eSTAR is not used for De Novo submissions or any other types of medical device submissions that require a different approach. However, it may be utilized in the future for a broader range of submissions as the FDA continues to enhance its electronic submission capabilities.

    Overall, the voluntary use of eSTAR provides medical device manufacturers with a convenient and efficient method for preparing and submitting certain types of premarket submissions to the FDA.

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