On 1 October 2025, a significant change will come into effect in the United States: The Food and Drug Administration (FDA) will only accept various applications for approval of medical devices in the format of the Electronic Submission Template and Resource (eSTAR). Since 1 October 2023, eSTAR has been available for all 510(k) submissions. Now, the eSTAR format is becoming mandatory for all applications. This applies to both US and international manufacturers of medical devices.
What is eSTAR?
The eSTAR template is an interactive, PDF-based document developed by the FDA to improve the quality and consistency of regulatory submissions. The aim of this measure is to structure submissions clearly and make them machine-readable, thereby increasing both the completeness of the documentation and the efficiency of internal processing. The ‘administrative review’, which was preceded by a detailed document review by the FDA and in which initial basic formalities were checked, is now a thing of the past.
The FDA describes the system as a ‘structured electronic submission template that mirrors the internal review process’. In other words, eSTAR not only reflects the requirements for submitting applications, but also the way in which FDA reviewers examine these applications. Features include logic checks, auto-completion (e.g. for product codes) and direct integration of the FDA 3514 (cover sheet) and FDA 3881 (indications for use) forms.
Transition Period and Timetable
The transition to eSTAR took place in stages:
- Oktober 2023: Beginn der eSTAR-Einreichung für die meisten 510(k)-Anträge.
- August 2024: Publication of guidance document for electronic applications, which also included de novo applications.
- 1 October 2025: From this date onwards, only applications in eStar format will be accepted.
Trivial but essential: Only the current eSTAR form is valid. For example, in February 2025, the latest comprehensive document version 5.5 was published, which is now mandatory.
Also interesting: Health Canada is currently testing the FDA eSTAR document for its own use. It could therefore be speculated that eSTAR could also become mandatory for the Canadian market in the future.
Consequences for International Manufacturers
Manufacturers who wish to place products on the US market must submit their approval applications in the form of an eSTAR document. This is because eSTAR is now mandatory for both 510(k) and De Novo applications.
A particular challenge for international manufacturers is transferring existing documentation and evaluations into the narrowly defined fields of the eSTAR document. Efficient transcription therefore requires precision in execution and a good knowledge of the content of technical documentation and FDA requirements.
For example, while MDR requires a comprehensive but relatively freely structured clinical evaluation, eSTAR requires the same information to be entered into specific fields, including cross-references and supporting documentation.
While the FDA has always set its own requirements, manufacturers previously had more freedom in the design of their systems. MDR-compliant documentation could largely be adopted and submitted as evidence in the appendix, as long as it met the content requirements; with eSTAR, more adaptation work may be necessary.
The FDA therefore no longer defines only the scope of product documentation, but also the form of submission down to the smallest detail. This simplifies and standardises the application review process on the part of the FDA – especially since eSTAR applications can be evaluated entirely by machine due to their uniformity – but complicates matters, particularly for smaller and innovative manufacturers.
Role of US-Agents
The FDA requires importers and manufacturers to appoint a local representative in the United States – known as a US agent. The US agent is primarily the point of contact for the US Food and Drug Administration (FDA). Unlike the EU rep, they bear no responsibility for placing products on the market.
BEO BERLIN offers the provision of the US agent as a service. Our colleague Stephanie is based in Texas and has been performing this role for more than 15 years. In addition, she is an expert on logistics issues in the USA. An ideal combination for fast, uncomplicated new registrations in the USA!
Role of BEO BERLIN
BEO BERLIN has been offering support for various FDA approval procedures for more than 15 years. The eSTAR requirement does not change the formal obligations of an applicant, but it does change the requirements for technical expertise. Whereas before eSTAR, minor errors in form or transmission could be identified and sometimes even corrected by an FDA clerk, the eSTAR framework requires absolutely correct input from the outset: any error in the form prevents the application from being submitted – that is how the eSTAR form is programmed.
This makes it more important than ever to have competent and knowledgeable experts to handle the application process, who are familiar with FDA requirements and at the same time have a deep understanding of, for example, European MDR conformity assessment procedures, so that the formal transfer of documentation can proceed smoothly.
Our recommendations for manufacturers
In addition to personal consultation with our experts, BEO BERLIN recommends the following for manufacturers with ambitions in the US medical device market:
Refer to the current eSTAR guidance document: Download the latest version of the guidance document from the FDA website.
Mapping documents: Transfer MDR/EU dossiers to the eSTAR structure at an early stage.
Use US Agent Service: Secure reliable and fast communication channels.
Adjust schedule: Allow additional buffer time for technical checks and validation.
What Does it all Mean?
With the extension of the eSTAR requirement to de novo applications, the FDA is continuing its digitalisation and automation strategy. For manufacturers interested in the US market, this means mandatory compliance with eSTAR requirements.
Manufacturers who already have products on the US market with a 510(k) application approved prior to the introduction of eSTAR should keep an eye on this development. The introduction of the De Novo requirement offers a good opportunity to prepare future 510(k) applications in eSTAR format at an early stage.
It can be helpful to have professional expertise at your side; as a long-standing service provider in the areas of FDA approval and US agent, BEO BERLIN is an ideal partner on your path to FDA reapproval.
Contact us to get answers to your questions about accessing the U.S. market.
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