eSTAR Publishing for Medical Devices
Structured. Compliant. Efficient.
Simplify Your 510(k) Submissions with eSTAR Publishing
The FDA’s electronic Submission Template And Resource (eSTAR) is now the preferred format for most 510(k) submissions. Designed to enhance clarity, consistency, and completeness, eSTAR reduces review times and minimizes common errors. GLOBAL helps device manufacturers navigate this new standard with expert eSTAR publishing support.
What Is eSTAR?
eSTAR is a dynamic, interactive PDF form developed by the FDA to streamline medical device submissions. It guides users through all required content sections and includes built-in validations to catch issues before submission. While eSTAR simplifies the submission framework, it introduces new formatting, technical, and data entry requirements that can challenge even experienced regulatory teams. GLOBAL ensures your eSTAR submission is:
- Technically compliant and validated for FDA acceptance
- Fully populated with required content and metadata
- Formatted and linked for ease of review
- Delivered on time and submission-ready
Our eSTAR Publishing Services include:
- Population of eSTAR template fields with validated content
- Integration of 510(k)documentation and labeling
- Hyperlinking, bookmarking, and PDF optimization
- Quality control review and submission readiness checks
- Coordination with regulatory writers and subject matter experts
- Final validation and packaging for FDA submission
Benefits of eSTAR Publishing with GLOBAL:
Accelerated preparation of 510(k) submissions using structured templates
Fewer errors and rejections due to built-in validations and expert review
Consistent formatting and content presentation across submissions
Seamless integration with your internal regulatory and quality teams
Experience That Supports Your Success
As regulatory expectations evolve, GLOBAL helps clients stay ahead. Our team has hands-on experience with eSTAR and has supported both traditional and abbreviated 510(k) submissions across a variety of device types. We combine publishing precision with regulatory insight to deliver high-quality, compliant submissions that meet FDA expectations.
What sets us apart?
Deep knowledge of 510(k) requirements and device classification
Familiarity with the FDA's eSTAR template and validation rules
Coordinated support across writing, formatting, and publishing
Scalable resources for large device portfolios or tight deadlines
Submit with confidence.
eSTAR is here to stay. Let GLOBAL help you adapt to this new standard with confidence, clarity, and speed.
Contact our publishing team today to learn how we can support your next 510(k) submission using eSTAR.
