Using the new eSTAR templates for a 510(k) submission and the FDA eSTAR draft guidance

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Using the new eSTAR templates for a 510(k) submission and the FDA eSTAR draft guidance

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In this video we review the new eSTAR templates for a 510(k) submission and we include information from the new FDA eSTAR draft guidance. We also addressed questions that were unanswered in our previous eSTAR training with responses directly from the FDA and from a third-party reviewer.
On September 29, 2021 the FDA released the new eSTAR draft Guidance for 510k submissions. This is a huge milestone because there have not been any draft guidance documents created for pilot programs. The draft indicates that the comment period will last 60 days (i.e. until November 28, 2021). However, the draft also states that the guidance will not be finalized until a date for requiring electronic submissions (i.e. submission via an ESG) is identified. The draft indicates that this will be no later than September 30, 2022. Once the guidance is finalized, there will be a transition period of at least one year where companies may submit via an ESG or by physical delivery to the FDA DCC.
There are no new format or content requirements in the eSTAR draft guidance, but the eSTAR template itself has several text boxes that must be filled in with summary information that is not specified in the guidance for format and content of a 510k. The information requested for the text boxes is a brief summary of non-confidential information contained in the attachments of the submission. Therefore, these boxes can information that would normally be in the overview summary documents that are typically included at the beginning of each section of a 510k.
If you are interested in downloading our template for the eSTAR cover letter and the table of contents planning tool, please fill in the registration form our on website. We will also notify you of new updates to the eSTAR template for 510(k) submissions.

Пікірлер: 7

@patrickaxtell6363 2 жыл бұрын

Regarding the symbols glossary, applicants only need to cite the attachment and page where the symbols glossary is included. You don’t need to cite anything else, and can type N/A if no symbols glossary was used.

@MedicalDeviceAcademy 2 жыл бұрын

Thank you Patrick. If anyone is looking for more guidance on labeling, creating an IFU, and the use of symbols...here's a link to a webinar on the topic: medicaldeviceacademy.com/how-to-write-instructions-for-use/

@user-dl9xc2bo7f Жыл бұрын

Ho w would you recommend naming the attachments in e-star? using the traditional 510k checklist or naming them in the order they're attached in e-star?

@MedicalDeviceAcademy Жыл бұрын

When we were using the 20-section format for a traditional 510(k), we always used the volume and document structure to make sure that we would not need to renumber everything when we add a document or make a change. The same rationale applies to the eSTAR. We have been using the same 20 volumes and assigning the next sequential number to the document in that volume. Going forward there will be more than 20 sections to the eSTAR and the number of sections will change. Therefore, it might make sense to create a pre-fix for the documents in each section rather than using numbers. For example: "Bio" for biocompatibility, "Rep" for reprocessing, "Ste" for sterilization, and "Emc" for EMC testing. It helps to assign document numbers, but you do not need to assign sequential numbers.

@user-dl9xc2bo7f Жыл бұрын

@@MedicalDeviceAcademy Ah yes, the abbreviated versions make a lot of sense as the document order in e-star is different from the traditional 510k Also adding subsections within a document (for e.g. Section 10 Device Description) also becomes a little challenging since sections like device description has 3 different attachments as opposed to 1 Thanks for your response!

@treythorsen225 Жыл бұрын

Can you attach a list of accessories or do you have to add each individually?

@MedicalDeviceAcademy Жыл бұрын

That's a great question Trey. The FDA eSTAR template asks you to list each accessory individually and identify it. In addition, there is a text box that you fill in to list the accessory and identify whether the accessory has a previous 510(k) or if you are including it in your submission. There is a question asking you if you want the FDA to perform a risk-based classification of the accessory if it has not previously be classified. Finally, there is a place to attach pictures or drawings of accessories. If you have a long list of accessories, you could attach the list and state that in the text box. I don't know if the the technical reviewer would reject the submission if you don't list each accessory using the button for "Add Accessory," but if the list is extremely long that seems like an appropriate solution.