US FDA 510(k) submission is a premarket notification required for medical devices intended for U.S. market entry. This pathway is essential for devices that are not exempt from FDA 510(K) and is not already legally marketed. Additionally, it is required for devices that have undergone significant modifications. FDA 510(k) submission preparation involves device testing, clinical data consolidation, and extensive documentation. Moreover, the submission has to be prepared per regulatory requirements. Hence, we have prepared this comprehensive guide to the FDA 510(k) submission for medical devices aiming to enter the U.S.
We at Pharmadocx Consultants specialize in US FDA 510(k) submission. As a reputed US FDA 510(k) consultant, we follow a unique approach that helps our clients achieve the approval effectively and efficiently. Moreover, we tailor our services as per client requirements. We carefully plan, make strategic decisions, and speed up the whole process. Additionally, we try to ensure your application is complete with all the information so that it does not move to the additional information (AI) request stage.
What is the US FDA 510(k) submission?
US FDA 510(k) demonstrates that a new device is “substantially equivalent” to a legally marketed predicate device not subject to Premarket Approval (PMA). It demonstrates the device in question is as safe and effective as the “substantially equivalent” device being sold legally in the US. The US FDA 510(k) submission process involves evaluating and comparing the device with the “substantially equivalent” or predicate device already being sold in the US market.
When is it required?
- For devices not exempt from 510(k) requirements and is not already legally marketed in US.
- When modifying an existing device in ways that affect safety or effectiveness.
Timeline
- Preparation time required is usually 4–5 months.
- FDA review time is up to 6 months.
Pre-submission (Q-submission) pathway
Pre-submission pathway allows you to request FDA feedback on specific aspects of your planned submission before your formal US FDA 510(k) submission. This optional but highly recommended step allows manufacturers to seek FDA feedback on testing protocols, substantial equivalence, and regulatory strategy. It will help align with regulatory expectations early on to avoid delays. Notably, feedback is non-binding but strategically valuable for shaping a robust submission.
- Purpose: To get early FDA feedback on testing protocols, substantial equivalence, regulatory strategy, etc.
- Process: Submit a detailed request with device description and specific questions. FDA responds within 60–75 days via teleconference or meeting.
Pre-submission pathway is very impactful in shaping your submission strategy.
What to include in a pre-sub request?
FDA expects a structured document with:
- Device description: Clear, concise overview of design, intended use, and technology.
- Regulatory history: Prior interactions, related submissions, or similar devices.
- Specific questions: Focused, well-formulated queries (e.g., “Is this predicate appropriate?” or “Will this biocompatibility protocol suffice?”).
- Testing plans: Summaries of bench, animal, or clinical protocols.
- Draft labeling: Especially if claims are novel or borderline.
- Meeting request: Indicate if you want written feedback only or a teleconference/video meeting.
Timeline and process of application
- Prepare and submit: Send your pre-sub application to the FDA.
- Acknowledgment: FDA confirms receipt and assigns a tracking number.
- Scheduling: If a meeting is requested, FDA typically schedules it within 60–75 days.
- Feedback delivery: Written feedback is provided in advance. Meetings (virtual or in-person) allow for clarification and discussion.
- Follow-up: You may submit a meeting minutes document for FDA confirmation.
Benefits of pre-submission pathway
- De-risking: Identify potential roadblocks (e.g., predicate selection, testing protocols, labeling claims) before they become formal deficiencies.
- Clarity: Gain insight into FDA expectations for clinical data, performance testing, software documentation, or biocompatibility.
- Efficiency: Well-prepared pre-submissions can shorten review timelines and reduce back-and-forth during the actual submission.
- Innovation support: Pre-submissions are especially valuable for novel technologies, combination products, or borderline classifications.
Best practices for regulatory success for pre-submission
- Ask targeted questions: Avoid vague or overly broad queries.
- Use FDA guidance: Align your protocols with recognized standards and industry quality benchmarks.
- Include risk analysis: Demonstrate your application has considered patient safety and device performance.
- Document everything: FDA feedback is non-binding but can be referenced in your submission.
US FDA 510(k) submission process and timeline
The duration of the FDA 510(k) submission process and timeline can vary significantly. It will depend on factors, such as the complexity of the device, the completeness of the submission, and any interactions required with the FDA. Usually, the FDA aims to complete the review process within 90 days of acceptance. However, actual timelines may be longer in the majority of cases of application. The US FDA 510(k) submission process is divided into five phases:
Phase I: Device selection and predicate identification
Select the medical device and models for US FDA 510(k) submission. Identify predicate device with the same indication and technology. Decide between 510(k) or PMA route. Appoint a regulatory consultant for a smooth regulatory journey.
Phase II: Technical preparation
Determine device code, regulation number, class. Identify biological testing needs. Then, send samples to lab. Draft 510(k) file and review risk analysis, labeling, shelf-life, etc. Conduct pre-submission for FDA 510(k).
Phase III: File compilation
Incorporate pre-submission feedback. Finalize testing and documentation. Review and prepare final draft.
Phase IV: Submission
Appoint US agent. Submit application via eSTAR to the FDA. Then, await FDA review comments.
Phase V: Post-submission
Respond to FDA queries. Modify and resubmit the application as required. Then, await FDA 510(k) clearance.
Checklist for US FDA 510(k) submission
We have prepared a detailed checklist to help you with your US FDA 510(k) submission.
- FDA Form 3601 – User Fee Cover Sheet
- CDRH Submission Cover Sheet – Predicate vs. New Device
- Cover Letter – Submission type, device description
- FDA Form 3881 – Indications for Use
- 510(k) Summary – Public-facing overview
- Truthful & Accuracy Statement
- Class III Certification (if applicable)
- Financial Disclosure (clinical studies)
- Declarations of Conformity
- Executive Summary
- Detailed Device Description
- Substantial Equivalence Discussion
- Proposed Labeling & IFU
- Sterilization & Shelf Life
- Biocompatibility Testing
- Software Documentation (for SAMD/SIMD)
- EMC & Electrical Safety (IEC 60601 standards)
- Bench Performance Testing
- Animal Testing (if applicable)
- Clinical Testing (if required)
Requirements for software-based devices
We have presented certain requirements specific for software-based devices.
- Significant software features and their functions including images, flow charts, and state diagrams.
- Role of the software, the intended user of the software, and the analysis methodology for the software performance
- Software platforms
- Final release version
- Provide the clinical workflow steps and mention if the device is interoperable
- Risk management per ISO 14971
- Cybersecurity documentation
- Software architecture diagrams
- Traceability matrix linking SRS, SDS, test cases, and risk IDs
- IEC 62304 compliance for lifecycle management
- Testing protocols and unresolved anomalies
5 Pro tips for a successful US FDA 510(k) submission
- Use comparison tables to demonstrate substantial equivalence
- Align labeling and IFU with 21 CFR 801 requirements
- Justify safety test omissions with scientific rationale
- Ensure traceability across software lifecycle documentation
- Engage in pre-submission to mitigate risk of RTA or major review comments
We at Pharmadocx Consultants have extensive expertise in US FDA 510(k) submission. Our team provides support for both traditional and software-based devices. We have deep expertise in predicate analysis, testing protocol selection, and FDA correspondence. We offer time-bound, cost-effective 510(k) solutions. To avail our services, email at [email protected] or call/Whatsapp on 9996859227.
Common FAQs
How to easily upload files for 510(k) submission?
Compress files where ever possible to help manage overall submission size. Always check the final submission files to ensure they meet the FDA’s requirements. Notably, ensure all links work, files are readable, and the submission is complete.
Any specific file structure for a 510(k) submission?
The 510(k) submission file should be well-organized. It should be divided into multiple files or sections. This not only makes it easier to upload the files but also helps the reviewers easily navigate the document.
How much is the total cost for a US FDA 510(k) submission?
The following are the fee for a submission (standard and small business): FDA review, documentation and US agent, biocompatibility / electrical safety (if applicable), performance tests, and validations fee.
Can an applicant withdraw an FDA 510(k) submission?
Yes, an applicant can withdraw the submission at any time before the FDA makes a final decision.
