What is preSTAR?

preSTAR is a new template introduced by the FDA to streamline the process for pre-submissions and 513(g) Requests for Information related to medical devices. It is part of the eSTAR system, an interactive PDF designed to assist users in submitting complete premarket submissions to the FDA. preSTAR helps device manufacturers obtain FDA feedback on classification, regulatory requirements, and other critical aspects of medical device development before formal submission.

What is the significance of preSTAR in submission of medical device information?

preSTAR provides significant value in the submission process for medical devices by allowing early interaction with the FDA. It facilitates:

• Pre-submission feedback: Manufacturers can obtain FDA's input on the regulatory pathway, device classification, and submission requirements.
• Clarity on regulatory requirements: It helps clarify whether a device requires premarket approval, such as a PMA or 510(k), and what regulatory steps are needed.
• Structured format: The template provides a structured format that ensures all relevant information is captured and aids in the preparation of comprehensive submissions, leading to more efficient regulatory reviews.
• Customization: preSTAR offers the flexibility to choose between different types of feedback requests (e.g., 513(g) Request, Pre-Sub Written Feedback, or Pre-Sub Meeting) based on the specific needs of the device.

What are the requirements for the preSTAR?

The preSTAR template requires the following:

• Product information: A comprehensive description of the device, including key design features, principle of operation, components, and proposed interfaces.
• Indications for use: The applicant must provide a proposed indication for use and specify whether the device is for prescription or over-the-counter use.
• Pre-submission correspondence: If there have been previous regulatory interactions, these must be included in the submission.
• Submission characteristics: Applicants need to describe the purpose of the pre-submission, including goals for FDA interaction and the type of future submission intended.
• Meeting requests (if applicable): Applicants can request a meeting with the FDA, specifying the length, type (teleconference or face-to-face), and a draft agenda with estimated times for each item.
• Question limits: The template allows a maximum of 10 questions for the FDA, and it provides guidance on submitting separate pre-submissions if more questions are needed.
• For 513(g) Requests: Applicants must clarify whether the device includes functions that are considered medical devices and need premarket submission, including details like product classification and regulatory requirements.

DDReg’s Capabilities

DDReg provides expert support to medical device companies that are looking to submit eSTARs or preSTAR to the US FDA. The team is equipped with in-depth technical knowledge and regulatory expertise for submissions to the US FDA, including compilation, review, validation, and submissions that are compliant and streamlined.