PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR.  A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission.  A 513(g) Request for Information is a means of obtaining FDA’s views about the classification and regulatory requirements for a particular device.

eSTAR Templates

As we have previously explained in our blog post here, eSTAR is an interactive PDF form designed to assist users in creating “complete” submissions. It includes questions about the product, that when answered, reveal additional information that should be supplied with a submission.  It includes “help text” that will assist the applicant in providing complete information.

PreSTAR

The PreSTAR template for pre-submissions and 513(g) Requests for Information is currently voluntary.  There is only one template for both in vitro diagnostic devices and non-in vitro diagnostic devices, which is different from other eSTAR submission templates.  If an applicant chooses to use it, it allows the user to choose either a “Request for Classification Information (513g)”, “Pre-Sub Written Feedback (Q-Sub),” or “Pre-Sub Meeting and Written Feedback (Q-Sub).”  Other planned options, which are not yet available, include: accessory requests, determination meetings, agreement meetings, expedited program entrance requests, study risk determination, expedited program interaction submissions, informational meetings, PMA 100-Day meetings, and submission issue requests.

PreSTAR for Pre-Submissions

The PreSTAR template for pre-submissions will look familiar to those who have been submitting 510(k)s using eSTAR with the same sections for Cover Letter/Letters of Reference, Applicant Information, Standards, General Product Characteristics, System/Kit Components and Accessories, Classification, Labeling, and Literature References.  However, the applicant is not required to include all attachments to complete the submission (e.g., package labeling is optional).  They are, however, required to minimally attach a comprehensive product description which should include the key design features for the principle of operation, how performance is achieved, any components or accessories used with the proposed device, and a description of all proposed interfaces.  Similar to other eSTAR templates, there is a section for indication for use statement.  The applicant is required to provide a proposed indications for use and select whether the device will be prescription use, over-the-counter use, or both.

There are sections in PreSTAR for a pre-submission that differ from the eSTAR template for marketing applications.  One of which is a section for “pre-submission correspondence and previous regulatory interactions.”  Depending on your answers the PreSTAR template will let you know if you should be using the PreSTAR.  For example, if you answer yes to the following question, “Do the provided questions relate to your marketing submission hold letter, CLIA hold letter, Clinical hold letter or an IDE letter?” a pop-up message instructs you to submit a Submission Issue Request (SIR) via eCOPY as the SIR Q-Submission via PreSTAR is currently not available.  If you have had prior submissions or regulatory interactions related to the product that is subject of the PreSTAR pre-submission, the template will require you to add in the submission numbers and attach the prior regulatory feedback.

Another section when used for a pre-submission is “submission characteristics.”  This section requires the applicant to provide an overall purpose of the submission, including goals for the outcome of the interaction with the FDA, what type of future submission the applicant intends to submit, and requires the selection of a maximum of four (4) category topics.  If you choose “not listed (applicant specified),” you will need to provide a category heading.  For each question submitted, the applicant will be required to choose the Topic Category.  While four topics may be applicable for many pre-submissions, this may be challenging for start-ups or applicants with very novel technology where the first pre-submission interaction often covers a broad range of topics, leaving specifics for follow-on pre-submission supplements.  A topic of “overall testing strategy” may be a helpful addition to the template to allow these broader, initial discussions.

The template allows up to ten (10) questions and will indicate when you have reached the limit of questions entered, noting that you can consider submitting separate pre-submissions for additional questions; see our previous blog posts here on pre-submissions and the effect limiting questions may have on speed of innovation of medical devices.   Further, by limiting the number of questions, it may lead sponsors to create more general questions that lack the level of specificity needed to tease out a specific issue or to combine questions in a way that make them more difficult for the Agency to address.  Either way, putting a hard limit on questions is not in the best interest of the pre-submission program.

The applicant can choose the length (i.e., 30 minutes or one hour) and type of meeting (i.e., teleconference or face-to-face) requested.  In addition, the applicant is required to provide a draft agenda with an estimated time for each item on the agenda.  The agenda at this point is usually quite general, with specifics added after receipt of FDA’s written feedback ahead of the meeting.  The applicant provides a list of attendees and if they are requesting any specific FDA staff to attend the meeting.  Additionally, the applicant is required to confirm they will be responsible for submitting the draft meeting minutes and must confirm they understand FDA’s policy against recording the meeting (either with audio or video).

PreSTAR for 513(g) Requests for Information

If the applicant chooses to submit a 513(g) Request for Information, there are two main sections to complete, “General Product Characteristics” and “Description.”   The intent of the questions in the “General Product Characteristics” section of the template is to answer the questions and provide FDA information about the functions the applicant believes are non-medical device functions or exempt device functions (i.e., not subject to premarket review).  In the “Description” section the applicant should describe any medical device functions of the product that would require a premarket submission.  Similar to other eSTAR templates, there is a section for providing the indication for use statement.  We assume this would be related to those functions that the applicant believes are medical device functions, since the applicant is required to select whether the device will be prescription use, over-the-counter use, or both as part of the indications for use statement.  This distinction between what sections are to be completed for non-device function and device functions could be confusing to the sponsor especially since there is no opportunity to explain the intended use of the product (which may include both device and non-device functions).  The template is set up such that it assumes the applicant understands which functions of the product would be subject to regulation, what the classification would be and if the function requires a premarket submission.  For example, the template includes a section for the applicant to classify the device functions by choosing the medical specialty, regulation, and product code.  This seems to defeat the purpose of submitting a 513(g) request, since most applicants are asking the FDA to determine if the product is a device, what the classification regulation might be, and whether a premarket submission (e.g., PMA or 510(k)) is required.

As with the eSTAR templates for premarket submissions, the preSTAR template introduces some complexity into the process that will take users time to navigate.  FDA has not provided any information on whether it remains voluntary or will be required in the future, but if it does become a requirement, as it has for 510(k)s, we hope the Agency will continue to make improvements to allow it to be useful for the wide range of pre-submissions and 513(g) requests that sponsors may submit.