510(k) Submission with the eSTAR template: processing times.
- SANRUBIO, LLC
- May 30
- 3 min read
Updated: Jul 5
Premarket Notification, commonly referred to as 510(k), is a regulatory requirement enforced by the U.S. Food and Drug Administration (FDA) for medical device manufacturers seeking to introduce new devices into the United States market.
The 510(k) process enables the FDA to assess whether a new device is substantially equivalent (SE) to a legally marketed device, known as the predicate device. Substantial equivalence is determined by comparing the new device's intended use and technical characteristics to those of the predicate device.
This rigorous evaluation ensures that the new device is as safe and effective as its predecessor, safeguarding public health while fostering innovation in the medical device industry.
Navigating the FDA's New eSTAR Requirement for 510(k) Submissions: A Comprehensive Guide
As of October 1, 2023, the FDA mandates that all 510(k) submissions be submitted electronically using the eSTAR template. This transition is designed to enhance efficiency, standardize the review process, minimize errors, and shorten response times. Below, we provide an in-depth guide to the updated process, including timelines and key considerations for each step.
1. Acknowledgment of Receipt
What Happens
Upon receiving your 510(k) submission, the FDA assigns a unique control number, referred to as the 510(k) number or K number (e.g., K123456).
Verification Steps
The FDA performs two critical checks:
Confirmation of the user fee payment.
Verification that the submission includes a valid eSTAR form.
Outcome
If both conditions are met, the FDA issues an acknowledgment letter to the contact listed in the submission, confirming the receipt date and assigned 510(k) number.
If either condition is unmet, the FDA sends a hold letter within 7 days of receipt.
2. Acceptance Review
Duration
Approximately 15 calendar days (potential delays may occur based on FDA workload).
What Happens
The FDA evaluates whether the submission meets the minimum requirements.
Possible Outcomes
Acceptance for substantive review.
Refusal to Accept (RTA): The submission requires revisions before proceeding.
Note: Applicants receiving an RTA have 180 days to address deficiencies. Failure to do so results in the withdrawal of the submission.
3. Substantive Review and Interaction
Duration
Up to 60 calendar days.
What Happens
A lead FDA reviewer conducts an in-depth evaluation of the submission’s content.
Potential Interactions
Interactive Review: Minor deficiencies are addressed in real-time.
Additional Information Notification (AINN): The submission is placed on hold pending further information.
Note: If an AINN is issued, applicants have 180 days to respond with a complete submission. Failure to meet this deadline results in withdrawal.
4. Final FDA Decision
Duration
Up to 90 calendar days from initial acceptance (may vary based on workload).
Expected Outcomes
SE (Substantially Equivalent): The device is cleared for marketing.
NSE (Not Substantially Equivalent): The device does not meet FDA criteria and cannot proceed.
Conclusion
The FDA's adoption of the eSTAR template has streamlined the 510(k) submission process, offering a standardized format that reduces errors and improves clarity. However, thorough preparation and strict adherence to regulatory requirements remain essential for success.
At SANRUBIO, LLC, our team of experienced consultants is ready to assist you in navigating the 510(k) process with confidence. From initial submission to final FDA decision, we ensure compliance at every step, helping you bring your medical device to the U.S. market efficiently and effectively.
Get in Touch
Contact us for personalized consulting and take the next step in your medical device journey with confidence.
References:
FDA. "510(k) submission process". https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
FDA. "eSTAR program". https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program