A Proven Track Record
Freyr has successfully helped various multinational device manufacturers across the globe get 510(k) approvals
We provide Successful Regulatory Strategy for guiding the product registration process
We achieve 100% Quality Compliance of technical documents required for 510(k)
We ensure Timely Compilationand Submission of 510(k) with minimum queries from the US FDA
Freyr 510 (k) Competencies
- Comprehensive US FDA Regulatory and Submission Strategy
- Identification of Predicate Device for Substantial Equivalence Analysis
- Identification of Applicable Standards
- Gap Analysis as per US FDA regulation and international standards
- Compilation of all sections of 510(k) Technical File in eSTAR format
- Publishing of eSTAR template
- Addressal of review deficiencies and AINN response
- Liaising services for Device Clearance
- Consultation services for addressing deficiencies
- Establishment Registration
- Device Listing & FURLS data base maintenance
- Device Lifecycle Management
Experience hassle-free and assured 510(k) approvals with Freyr
Why Choose Freyr?
![Accelerate your 510 (k) Approval Process]( "Accelerate your 510 (k) Approval Process")
Regulatory Expertise
Dedicated 510(k) experts ensuring seamless approval of the 510(k) pathways
![Accelerate your 510 (k) Approval Process]( "Accelerate your 510 (k) Approval Process")
Faster Approvals
Proven strategies to expedite 510(k) submissions, reducing time-to-market
![Accelerate your 510 (k) Approval Process]( "Accelerate your 510 (k) Approval Process")
Customized Solutions
Tailored services for your specific device and needs for successful FDA 510(k) clearance
![Accelerate your 510 (k) Approval Process]( "Accelerate your 510 (k) Approval Process")
Risk Mitigation
We ensure your submission meets FDA requirements, minimizing compliance risks
Frequently Asked Questions (FAQs)
In order to submit a 510(k) using the FDA's eSTAR pilot program, you will have to download and complete the eSTAR template from the FDA's website, ensuring all required information and attachments are included. Validate the submission using the template's built-in tool, then submit the final PDF through the FDA's Electronic Submissions Gateway (ESG).
Before initiating it’s advisable to confirm that your device and submission are eligible for the eSTAR program. You can check via guidelines available or through a 510 (k) consultant.
In certain cases, the FDA has classified specific medical devices as "exempt” which means that the medical device is not required to undergo the usual 510(k) submission process to obtain FDA clearance. For instance, low-risk devices with well-established safety profiles and minimal risks to patients may qualify for this exemption.
However, 510(k) exempt devices still have to comply with certain regulatory norms specified by FDA.
Yes, a Quality Management System (QMS) is typically required for a 510(k) submission. The manufacturers going for 510(k) has to follow Quality System Regulation (QSR) (21 CFR part 820).
