Understanding FDA’s NEW Draft Guidance on the De Novo eSTAR Program

Oct 11, 2023 | News |

While the FDA has issued extensive guidance to outline premarket submission requirements and relevant acceptance criteria, manufacturer discretion in the implementation of these requirements often results in a lack of uniformity in the way submissions are prepared and presented. This variability often hinders the FDA’s prompt and efficient review of incoming submissions. The Electronic Submission Template and Resource (eSTAR) program aims to correct these inefficiencies by providing standardized electronic submission templates for all premarket submission pathways [1]. On September 29, 2023, the FDA issued a new draft guidance document, “Electronic Submission Template for Medical Device De Novo Requests,” which formally expanded the program to include De Novo classification requests [2]. This document marks the FDA’s latest step toward the full implementation of the eSTAR program for all types of market applications. 

Background 

Mandate for Electronic Submission 

Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that all pre-submissions, submissions, and submission supplements for devices under relevant sections of the FD&C Act be filed in an electronic format. To fulfill this mandate, the FDA intends to develop individual guidance documents for each premarket submission type. These final guidance documents are responsible for establishing submission-specific formatting standards, a timetable for implementation, as well as criteria for waivers of and exemptions from the requirements [2].  

Recent Draft Guidance 

The recently issued guidance document, “Electronic Submission Template for Medical Device De Novo Requests,” is a precursor to the final guidance that will mandate electronic submission for all De Novo classification requests. This draft guidance offers information related to the preparation of electronic De Novo submissions including formatting structure, submission content, the submission review process, as well as criteria for waivers and exemptions from these requirements. 

The Use of eSTAR 

The eSTAR is an interactive PDF form that guides applicants through the process of compiling a medical device submission. This standardized template promotes submission quality and consistency by automating content population, providing built-in forms, and integrating databases to enable access to device-specific standards and FDA guidance documents. Additionally, by aligning the form’s content and structure with the internal Submission Memo and Review Template (SMART) used by FDA reviewers, eSTAR aims to facilitate submission completeness and improve review efficiency [1].  

Submission Content for a De Novo Request  

The guidance specifically provides a high-level overview of the proposed structure and content of the De Novo electronic submission template. As outlined in Table 1 of the guidance document, De Novo applicants should provide: 

Information Requested   Description 
Submission Type  As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using the finalized 510(k) eSTAR template. eSTAR is also available for De Novo submission and Pre-submission applicants for voluntary use. 
Cover Letter / Letters of Reference  Submission of a cover letter and any reference documentation that identifies prior submissions relevant to the subject device. 
Applicant Information  Identification of relevant applicant information, as outlined by Form FDA 3514, Sections B and C. 
Pre-Submission Correspondence & Previous Regulator Interaction  Information regarding prior or ongoing regulatory interaction involving the subject device. This may include, but is not limited to, submission numbers for a prior not substantially equivalent (NSE) determination, deleted or withdrawn 510(k) submissions, Q-submissions, or Investigational Device Exemption (IDE) applications. 
Consensus Standards  Identification of any consensus standards with which the applicant claims compliance, including both FDA-recognized and non-recognized standards. 
Device Description  Descriptive information for the device, consistent with the requirements outlined in 21 CFR 860.220(a)(6). This includes, but is not limited to, a description of the device’s primary mechanisms of operation, proposed conditions of use, and reasonably known alternative practices or procedures.  
Proposed Indications for Use  Identification of the proposed indications for use of the device. This includes a general description of the disease or condition that the device is intended to treat, diagnose, or mitigate, as specified in 21 CFR 860.220(a)(5). 
Classification  Identification of the proposed classification for the subject device. This includes classification summary information in accordance with 21 CFR 860.220(a)(8). 
Benefits, Risks, and Mitigation Measures  A summary of the probable health risks associated with use of the device, along with proposed risk mitigation strategies. The applicant should also provide evidence to demonstrate that the probable benefits of device use outweigh any residual risk. 
Labeling  A submission of the proposed labeling of the device, consistent with the requirements of 21 CFR 860.220(a)(18). 

 

Where applicable, the applicant should also supply the required information to assess reprocessing, sterility, shelf life, biocompatibility, software/firmware, cybersecurity and interoperability, electromagnetic compatibility, electrical safety, mechanical safety, wireless and thermal safety, as well as performance testing. 

Submission Review  

As part of the eSTAR program rollout, the FDA plans to introduce a virus scanning and technical screening process as the initial step in the acceptance review process [2]. The technical screening is an automated process which aims to verify that eSTAR responses align with the device description and confirm that the applicant has included at least one relevant attachment for each applicable attachment-type question. The screening process is expected to occur within 15 calendar days of FDA receiving the De Novo eSTAR, provided that the appropriate user fees have been paid. If an eSTAR is incomplete upon submission, the applicant will be notified via email and the submission will be placed on hold for up to 180 days.  

If a submission passes technical screening, the De Novo request will proceed to FDA review. Following review and acceptance of a De Novo eSTAR submission, the FDA will notify the applicant electronically. 

Applicable Waivers and Exemptions 

Upon finalization of this draft guidance, FDA intends to exempt the following De Novo submission information from the electronic submission requirements:  

  1. Interactive review responses 
  2. Amendments, including appeals and requests for supervisory review, substantive summary requests, change in correspondent amendments, and amendments after final decision (i.e. add-to-files) 

The FDA has not identified any circumstances appropriate for waiver of the De Novo electronic submission requirements and therefore does not intend to grant waiver requests [2]. 

Call to Action 

Interested parties may submit comments on this draft guidance at this link prior to November 28, 2023. Following this public comment period, the FDA intends to publish a final guidance by September 30, 2025, which will mandate the use of eSTAR for all De Novo classification requests following the specified implementation date [2]. Until the finalization of this draft, eSTARs may be used voluntarily for the submission of De Novo requests. 

Link to FDA’s website for more information: eSTAR Program | FDA 

Have questions about navigating the De Novo eSTAR submission process? Contact MEDIcept for help at sales@medicept.com.

Citations 

[1] C. for D. and R. Health, “eSTAR Program,” FDA, Oct. 2023, Accessed: Oct. 10, 2023. [Online]. Available: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program 

[2] “Electronic Submission Template for Medical Device De Novo Requests – Draft Guidance for Industry and Food and Drug Administration Staff”. 

Abby Rieck – Associate Medical Device Consultant