Starting on October 1, 2023, all 510(k) submissions, unless exempted, will need to be submitted electronically using eSTAR. eSTAR, which is short for Electronic Submission Template and Resource, is a dynamic PDF submission template that contains automation, guides, integrated databases, integrated policies and procedures, and automatic verification to help users prepare a comprehensive medical device submission.
Rimsys recently hosted a webinar, eSTAR submissions overview and live Q&A with FDA, to help the medtech community prepare for the quickly approaching eSTAR deadline. Patrick Axtell, Assistant Director for Tools and Templates Team, and Sajjad Syed, Software Engineer for Tools and Templates Team, from FDA joined our panel of Rimsys regulatory experts to provide an overview of eSTAR, demo, and live question and answer session. If you're interested in watching the webinar replay, you can find it here.
Due to high participation, we couldn't answer all questions live. This blog post provides Patrick's and Sajjad's answers to questions we couldn't get to during the webinar. Read below to learn what other industry professionals want to know about eSTAR!
You may number attachments how you prefer, this includes numbering attachments according to the previous section numbers of the Format for Traditional and Abbreviated guidance document. However, the numbering hierarchy in the IMDRF documents, which the attachment questions in eSTAR correlate to, may be better, since that numbering scheme is internationally harmonized. So for example, if you are using the nIVD eSTAR, the IMDRF document specifies the Comprehensive Device Description would be numbered 2.04.01: https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-190321-nivd-dma-toc-n9.pdf.
Yes, the next IVD eSTAR update will fully support Dual submissions, and the workaround we were previously implementing will no longer be needed. CLIA waiver submissions will continue to be submitted via current methods, and are not required to use eSTAR after Oct 1, 2023.
You need to choose to open eSTAR in the default application from within the cloud application you use, you can’t just click on it, since it will open in the browser, and browsers can’t open dynamic PDFs like eSTAR, Form 3881, Form 3514, and other forms FDA uses.
We can’t say that all cloud applications will work, but using Box does work. Once eSTAR is loaded in, click on the three dots, then choose the application you have installed, see screenshots below. I have Adobe Acrobat 2017 and Adobe Acrobat Pro both installed.
Be aware that every time you save the form, you upload it back into the cloud, so depending on how large it is and how fast your internet connection is, it may take many seconds to save each time, though you will see a progress bar.
510(k) eSTARs, like 510(k) eCopies, can be submitted by foreign applicants.
Yes, by the end of 2023, eSTAR for PMA will be released. Similar to eSTAR for 510(k), there will be a pilot, guidance, and a transition period before it becomes mandatory.
We are at the mercy of updating when policies are updated, which is irregular and unpredictable. Please email CDRH management and recommend a more consistent (e.g. quarterly) policy deployment schedule so that eSTAR can also have a more predictable deployment schedule. We are updating approximately one to every two months currently. Please be sure to read the Version History on page 1 of eSTAR regarding versioning and which version to use.
This is a regulatory and policy question, and we are not sure what is meant by the statement “be handled.” Please reach out to OPEQ Submission Support OPEQSubmissionSupport@fda.hhs.gov with this question and they will direct your question appropriately.
eSTAR updates are almost exclusively timed according to policy updates, which the Tools and Templates Team has no control over. The T&T Team, as well as other groups in CDRH, are pushing for a quarterly update, where any policy updates in a quarter have an implementation date set for the beginning of the next quarter (e.g. Oct 1st, Jan 1st, Apr 1st). Please email Center management and promote this.
The Format guidance, as well as the eCopy guidance, RTA guidance, and many other guidances, no longer apply for eSTARs. Eliminating the applicability of guidances - simplifying the preparation process - is something we are proud of doing. You do not need to follow the numbering of this guidance. See response above, where we recommend using the IMDRF numbering scheme instead, which is internationally harmonized.
Depending on the type of submission you have selected (e.g. 510(k), De Novo, then Traditional, Special, Abbreviated), certain sections will become visible and active and some of them will be disabled. However, the bookmark pane will show all the sections in the entire eSTAR. Hence, please fill the sections that are visible to you since they are based on your selections. For example, if you have selected a Traditional 510k, the “Benefits, Risks and Mitigation Measures” section is not applicable. Hence it is not displayed and clicking on it leads a user back to the first page of the eSTAR. However, if you select “Special” as the 510k you are submitting, the “Benefits, Risks and Mitigation Measures” section does become applicable, and is displayed if you click on the bookmark. Also note that if you select De Novo, the section does become active as well. Another point to note is that for a Traditional 510(k) submission, if you do want to submit a Risks, Mitigations, Benefits report, you can attach it in the Performance Testing --> Bench Testing section of the eSTAR and identify it as “Other Non-Clinical Evidence”.
Hemocompatibility endpoint information, including Hemolysis, Complement Activation, and Thrombogenicity information, will appear depending on the tissue contact type and duration you choose. If you choose Implant Device >30 days, you will see this tab appear for example. The tabs that show are based on our Biocompatibility guidance.
There are four textboxes like this in eSTAR. The specifications, characteristics, etc., of the device should not be provided in these textboxes. Instead, these textboxes should be used to refer to the attachments where these controls or recommendations are found, per each specific recommendation. These textboxes do expand as text is typed in, if needed. Keep in mind that the special controls, device-specific guidance citations would be divided among these four textboxes.
Advertisements and promotional materials are included under the Other Labeling, and within the sub-attachment type "Other Labeling and promotional material" since this is consistent with Internationally harmonized document N9 and N13. As the help text states, whether you actually need to attach it at all (it is an optional attachment) is dependent on the jurisdiction. For FDA, you would need to reach out regarding your device and current policy at firstname.lastname@example.org.
There are many efficiency gains with eSTAR, this is not an exhaustive list. The eSTAR website also includes some of this information.
-eSTAR complements the reviewer's internal smart review template used to review the submission (i.e. the questions correlate). Therefore the reviewer is getting what they are expecting
-eSTAR provides a standardized format so that the reviewer (and applicant) always know where to find certain information
-eSTAR auto-updates many aspects of the submission, most notably it ensures the content is present negating the need for an RTA review by the reviewer, and therefore RTA holds
-eSTAR autocompletes information that you enter, ensuring you never need to enter the same information twice
-eSTAR includes built-in databases that ensure you see the information pertinent to your device (e.g. device-specific guidances), classification information automation, and the standards database, for auto-filling standards info accurately
-eSTAR has many forms built in, so that you don’t need to attach or upload them (e.g. T&A statement, Form 3514, 510(k) Summary, Declaration of Conformity, Form 3881)
-eSTAR guides the applicant through what is needed throughout, ensuring we collect everything that needs to be provided, and you know how to do it correctly
-eSTAR is collecting submission data in a structured format, which will help automate many aspects of our processing. This will provide applicants and reviewers many benefits (e.g. automating the submission log-in process, therefore permitting reviewers to receive a submission within minutes of when the submission is uploaded in the CDRH Portal)
-eSTAR is intended to be used as a resource also, since it consolidates all the information needed (e.g., regulation links, guidance links, submission process information) to prepare a submission