The FDA’s new electronic Submission Template And Resource (eSTAR) is revolutionizing the 510(k) submission process for medical devices. This interactive PDF form not only streamlines the submission process but also integrates multiple resources, ensuring a comprehensive and high-quality submission. With the mandatory transition to eSTAR submissions starting October 1, 2023, it’s crucial for medical device manufacturers to familiarize themselves with this tool.

Transitioning 510(k) Submissions to eSTAR – Are You Ready?

If you are planning to market a medical device in the US, you may need to submit a premarket notification, also known as a 510(k), to the FDA. A 510(k) is a submission that demonstrates that your device is substantially equivalent to a legally marketed device. The FDA reviews your 510(k) to determine whether your device is safe and effective for its intended use.

But how do you prepare and submit your 510(k)? The FDA has developed a new tool to help you: the electronic Submission Template And Resource (eSTAR). The eSTAR is an interactive PDF form that guides you through the process of creating a comprehensive and high-quality 510(k) submission. The eSTAR has many benefits, such as:

  • It integrates multiple resources, such as guidance documents and databases, to help you find the relevant information for your device.
  • It has a standardized format that is compatible with the FDA’s internal review templates, which can improve the efficiency and consistency of the review process.
  • It has built-in verification features that check for completeness and accuracy of your submission, which can reduce the chances of receiving a refuse to accept (RTA) or additional information (AI) request from the FDA.
  • It allows you to submit your 510(k) online through the CDRH Customer Collaboration Portal (CDRH Portal), which can save time and resources.

The eSTAR is free and available for voluntary use by all medical device applicants who wish to submit 510(k)s and De Novo requests to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER). The eSTAR is now available for use with combination products for these submission types.

Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR. Therefore, it is important to familiarize yourself with this tool and start using it as soon as possible.

To use the eSTAR, you need to follow these steps:

  1. Download the proper eSTAR PDF template from the FDA website and save it before you open it in Adobe Acrobat Pro or other PDF editing software.
  2. Read, understand, and follow the directions in the Introduction, Key, FAQ, and Version History sections of the eSTAR PDF template.
  3. Fill in the template accordingly. The template is only used for constructing, not submitting, your submission. The directions at the end of the template provide instructions on how to submit.
  4. Submit your eSTAR online through the CDRH Portal or by mail to CDRH’s Document Control Center (DCC). You do not need to provide an Indications for Use page, a Premarket Review Submission Cover Sheet, or a Declaration of Conformity with your eSTAR since they are built into the eSTAR PDF.

Review Timeline for eSTAR Submissions

After the FDA receives an eSTAR submission, it is 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 submission is not complete when submitted, the FDA will notify the submitter by email and identify the incomplete information. The submission will be placed and remain on hold for 180 days or until a complete replacement eSTAR is submitted to the FDA. 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).”

The Importance of a Robust Quality Management System (QMS) for Medical Device Manufacturers:

A robust Quality Management System (QMS) is of paramount importance in the 510(k) submission process and the eSTAR program. Here’s why:

  1. Regulatory Compliance: Medical device companies are required to establish and follow a QMS per FDA regulations. A QMS ensures that a company is compliant with the necessary regulations and standards, which is crucial for the success of a 510(k) submission.
  2. Design Controls: The FDA’s quality system regulations are very clear. Design Controls are required during the product development process. A QMS helps in documenting these Design Controls, which is a critical aspect of the 510(k) submission process.
  3. Risk Management: A QMS also aids in documenting Risk Management, another vital component of the 510(k) submission process. It helps identify and mitigate potential risks associated with the medical device, ensuring its safety and effectiveness.
  4. Preparation for Inspection: Registering your facility and listing your product establishes you as a target for inspection. A robust QMS prepares you for such inspections by ensuring that your processes, procedures, and responsibilities are well-documented and compliant with quality policies and objectives.
  5. Avoiding Pitfalls: Medical device companies neglecting Design Controls, Risk Management, and QMS in their quest for 510(k) market clearance may not realize the perils of their mistakes for a couple years. A robust QMS helps avoid such pitfalls.

The eSTAR program is part of the FDA’s efforts to modernize and streamline the medical device review process and to promote timely access to safe, effective, and high-quality medical devices. By using the eSTAR, you can help yourself and the FDA achieve these goals.  A robust QMS is not just important but essential for the success of a 510(k) submission and for navigating the eSTAR program effectively.  Whether you are a startup going through the design and development phases on your first product and looking to understand the regulatory landscape to bring your product to market, or you’re a veteran medical device manufacturer looking to improve your QMS to improve your ability to meet regulatory requirements, improve design and development accuracy and efficiency, and reduce risk of rejection during the pre-market approval, we’ve got solutions to help.  Reach out to request a demo of our robust suite of QMS applications tailor-made to improve cross-functional communication, improve design and development and market approval processes, and better meet regulatory requirements. You can trial all our 20 applications at no cost and with no obligation during a 30-day proof-of-concept to see for yourself how we can help your organization to work intelligently.

IntellaQuest

IntellaQuest provides a Quality Management System which is a  completely integrated single system for Life Sciences enterprise-level QMS. It provides a seamless management of all key needs of a QMS: non-conformance, complaints, CAPA, Document Control, Audit, Supplier Quality, Training, and Management of Control, etc.

The core solution set includes DocuQuest, PeopleQuest, PRRQuest & AuditQuest which help Life Science companies to:

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