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FDA 510k submission

FDA 510k Submission

FDA 510k Submission is made to the food and drug administration to demonstrate that the device is substantially equivalent to a legally marketed predicate medical device that is not subject to premarket approval.

 

A 510k clearance is required when you plan to market a device in the U.S. that is not exempt from 510k requirements and is not already legally marketed. It is also required when there is a significant change or modification to an existing device that could affect its safety or effectiveness. Preparation involves gathering all required documentation, conducting necessary testing, and ensuring that the submission meets all regulatory requirements.

 

An FDA 510k Submission document preparation including device testing, and clinical data consolidation takes up almost 4 to 5 months. Post submission to the FDA generally take up to 6 months, for closing the review queries. Engaging with a regulatory consultant can help ensure a complete and compliant submission.

 

FDA 510k Consultants will carefully plan, make strategic decisions, and speed up the whole process without RTA or a large number of additional information requests or major review comments. All foreign manufacturers are requested to have a US Agent for FDA correspondence officially.

 

Note: The service of the US Agent is different from the US Agent service for Establishment Registration.

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FDA 510k Pre or Q Submission

The FDA 510k Pre or Q Submission program allows medical device manufacturers to obtain FDA feedback on various topics such as test selection, standards, testing protocols (Biocompatibility, safety, performance), substantial equivalence, regulatory pathway, or any other specific technical issues before submitting a formal application

 

An FDA Premarket Submission is typically initiated by submitting a detailed request to the FDA that outlines specific questions or concerns. The request should include a description of the device, regulatory history, specific questions for FDA feedback, and supporting information. The FDA generally schedules a meeting (teleconference or in-person) within 60 to 75 days of the request to discuss the questions and provide feedback.

FDA 510k Submission

Benefits of Pre 510k Submission

Although Pre / Q-submission is not mandatory, we often recommend customers do so to gain an FDA view of the documents and if you have specific questions to the FDA to clarify. The consultants use this provision to seek valuable feedback on various topics, such as costly bench and animal testing, and clinical trials.

 

Early feedback from FDA help improve the quality of the files and avoid potential pitfalls and ensure their FDA 510k submission early clearance. It also expedites the overall review process by addressing critical issues before the formal submission. Pre-submission allows in aligning the requirements, reducing the risk of delays and rejections or shorter the total review times

 

It is important to note that the feedback provided during a Pre-Sub is non-binding, it can be a strong indicator of the FDA’s expectations, but it is very crucial to write/ask the questions and arrange supporting information to get good feedback in response.

We offer the best guidance and solutions for FDA 510k submission to worldwide manufacturers and specification developers. Our services are time-bound and economical. We match prices. So partner with us and experience the difference firsthand.

FDA 510k Submission Timeline

The duration of the 510k submission process and timeline can vary significantly depending on factors such as the complexity of the device, the completeness of the submission, and any interactions required with the FDA. Generally, the Food and Drug Administration aims to complete the review process within 90 days of acceptance, but actual timelines may be longer in the majority of the cases of applicants.

PHASE I

Stages

Activity

Responsibility

Timeline

1

Select the Device and models
for 510k submission

CLIENT

20 Days

2

Identify Predicate Device with the same
indication and technology

CLIENT + I3C

3

If NOT substantially equivalent, follow the PMA route or, if substantially equivalent, follow the 510k route

CLIENT + I3C

4

Appoint I3CGLOBAL as Technical Consultants
and US Agent

CLIENT

PHASE II

5

Identify Device Code and Regulation Number along with verification of Predicate Device, indication & technology.

 I3C

90 Days

6

Identify the device Class and guidance document

 I3C

7

Biological evaluation and test requirement identification in line with the predicate device

I 3 C

8

Samples send to the Laboratory

CLIENT

9

Evaluation of equivalent device compilation

 I3C

10

Drafting of 510k file in line with available FDA guidance document.

 I3C

11

Review of Risk analysis, Equivalent device data, Biocompatibility Test/Safety test protocols

CLIENT + I3C

12

Review of Labels, User Manual/IFU, Shelf-life records/lifetime calculation, and pre-clinical study evidence

CLIENT + I3C

13

Pre 510k submission

CLIENT + I3C

PHASE III

14

Compilation of 510k file by incorporating the pre-submission comments

 I3C

90 Days

15

Compilation of Pre-clinical and Biocompatibility and Safety testing

 I3C

16

Compilation and release of the final draft

I 3 C

17

Review submission file

 I3C

PHASE  IV

18

US Agent Appointment

CLIENT

20 Days

19

Review payment

CLIENT

20

eSTAR submission of file to FDA

 I3C

21

Receipt of acknowledgement

CLIENT

22

Wait for the review comments

CLIENT

90 Days

PHASE V

23

Modify the submission file and provide additional supporting documentary evidence as per FDA review comments

CLIENT + I3C

60 Days

24

Re-submission

 I3C

10 Days

25

Wait for the review comments or FDA 510k clearance letter

CLIENT

90 Days

FDA 510K Submission Checklist

510K Section

Topic

510k file Contents

Section 1 Medical Device User Fee Cover Sheet (Form FDA 3601)
The Medical Device User Fee Cover Sheet is essentially a payment receipt containing basic information and the type of submission.
Section 2 CDRH Premarket Review Submission Cover Sheet
The CDRH Premarket Review Submission Cover Sheet is a document of around 5 pages, and it includes nine different sections. The initial sections A through D are quite simple and require basic information about the submission type, the reason for submission, and the applicant’s details.

However, Sections E and F can be tricky. It is recommended to take a moment to carefully read and understand these two sections. Section E asks for information about the predicate device, while Section F asks for information about your device.The problem is that both sections are listed one after the other, with no white space to separate them. Although there is a black line separating them, it can still be confusing. As a result, people often make the mistake of adding the predicate device name in Section F instead of their own product name.

Section 3 CDRH Premarket Review Submission Cover Sheet
The cover letter serves as an introduction to your submission, and it should be concise yet comprehensive.
  • Type of 510(k) Submission: Specify whether it is Abbreviated or Traditional.
  • Device Description: Clearly state your device type in common terms.
  • Submitter Information: Include the 510(k) submitter’s details.
  • Contact Information: Provide the name, title, and phone number of at least one contact person.
  • Confidentiality Preference: Indicate your preference for continued confidentiality in accordance with 21 CFR 807.95.
  • Recommended Classification: Suggest a classification regulation and class (I, II, or III).
  • Review Panel and Product Code: Mention the review panel and FDA product code.
  • Prior Correspondence: List any related FDA document numbers from prior formal correspondence (e.g., IDE, pre-IDE, 510(k), PMA, RFD).
Section 4 Indications for Use Statement (FDA Form 3881)
This section is crucial as it defines the intended use of your device. It’s important to align the level of specificity with that of the predicate device to avoid additional testing or revisions. Over-specifying can raise questions about safety and efficacy, potentially leading to extended time to market.
Section 5 510(k) Summary
The summary containing the essence of your device and submission

 

Remember that the FDA makes this summary public within 30 days of their decision, so it’s important to balance the inclusion of sufficient details while meeting the FDA’s minimum requirements and maintaining strategic confidentiality.

 

The summary should encapsulate the essence of your submission, including information from the cover letter, a comparison of substantial equivalence, and a synopsis of the testing performed

Section 6 Truthful and Accuracy Statement
This section is a declaration confirming the truthfulness and accuracy of the information in your submission.  The FDA provides the exact wording for this statement. Your role is to include this statement verbatim in your submission, thereby certifying the integrity of your submission’s content.
Section 7 Class III Summary and Certification
If your device is Class II, this section will simply contain a statement:
“This device is not a Class III device”
If your device is Class III and does not require PMA, provide a statement and then include a summary addressing safety/effectiveness issues and supporting data.
Section 8 Financial Certification or Disclosure Statement
If your device did not undergo clinical studies, include a single sentence: “No clinical studies were performed to test this device.”
If clinical studies were conducted, you’ll need to complete the appropriate FDA form. There are two forms:

  • Financial Certification: Used if the payment to clinical investigators was solely for the study costs without additional incentives.
  • Disclosure Statement: Required if the clinical investigators were paid beyond the study costs. This form also necessitates details on mitigating potential bias.
Section 9 Declarations of Conformity and Summary Reports
This section involves declarations related to compliance with specific standards or regulations and summary reports of such compliance. Typically, this includes references to the standards or regulations your device conforms to and summary reports that demonstrate this conformity.
Section 10 Executive Summary
This section provides an overview of your device, including comparisons with the predicate device and a summary of all testing conducted.
Section 11 Device Description
This section in a 510k submission requires a comprehensive description of your device, extending beyond the basic descriptions used in earlier sections.

 

The goal here is to give the FDA reviewer a thorough understanding of your device, laying the groundwork for the substantial equivalence Discussion.

  • Detailed drawings from design outputs, including dimensions for each model/variant,
  • Details about accessories, and components.
  • Device specifications of components that come into patient contact.
  • Compliance with any device-specific guidance documents, if applicable.
Section 12 Substantial Equivalence Discussion
 

Demonstrate step-by-step how your device is similar or equivalent to the predicate in terms of indications for use, technology, and performance.

 

 

Prepare a comparison table made in an easy-to-read table that highlights key similarities and differences without giving exhaustive information

Section 13 Proposed Labelling
 

This section encompasses all labels and other written, printed, or graphic matter upon the immediate container of any medical device

Include any relevant product information from your website, as the FDA considers this part of your labelling.

 

Specimen Label (Primary, secondary and or tertiary)
Specimen IFU / Packing inserts in the English language

 

Name and Place of Business (21 CFR 801.1)
Intended Use 21 CFR 801.4
Adequate Directions 21 CFR 801.5
False or Misleading Statements 21 CFR 801.6
Prominence of Statements 21 CFR 801.15

 

Exemptions may be granted in those instances where device labelling lacks sufficient space for required labelling under conditions.

Section 14 Sterilization and Shelf Life
The 510k submission explicitly state if your device is non-sterile.

 

Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide (EtO) gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide).

 

Keep in mind that not all products require shelf-life testing. If your product is less likely to degrade over time, explain why shelf-life testing is not applicable.

For sterile devices, provide evidence of sterility at the end of the product’s shelf life and that the device performs as expected throughout its shelf life. Include shelf-life testing results, which may involve accelerated ageing tests.

 

Device shelf-life claims must be supported with appropriate testing data.

Section 15 Biocompatibility
 

 

If any part of your device comes into direct or indirect contact with patients, demonstrate that the materials used are safe and compatible with their intended use.

 

FDA may give an exception if your device is identical in material and manufacturing to the predicate device.

Individual test protocols
Reports of biocompatibility testing.
Section 16 Software (Only applicable for Software device manufacturers)
For SAMD or SIMD devices the 510k should give an appropriate definition of the software’s level of concern (minor, moderate, or major) and provide your rationale for this classification. Documentation Level Evaluation
A statement indicating the Documentation Level for the device and a description of the rationale for such documentation level.Software Description

  • Overview of significant software features and their functions including images, flow charts, and state diagrams.
  • Describe the role of the software, the intended user of the software, and the analysis methodology for the software performance
  • Mention the software platforms that are used
  • Mention the final release version
  • Provide the clinical workflow steps and mention if the device is interoperable

 

Risk Management File

  • Risk management plan
  • Risk Assessment
  • Risk Management Report

In compliance with ISO 14971 for Safety Risk Management.

 

Cybersecurity Risk Management File
Cybersecurity plan, security risk assessment demonstrating that risks have been appropriately mitigated and VAPT test report.

 

Software Requirements Specification (SRS)
The SRS documents the requirements for the software like

  • Inputs and outputs
  • Functional and capability requirements that the software will perform
  • Software-driven alarms, warnings, and operators’ messages
  • Security requirements
  • Data definition and database requirements
  • Installation and acceptance requirements
  • Hardware
  • Programming language
  • Compiler version
  • Performance
  • Interfaces between software and the other system
  • User interface requirements implemented
  • Requirements related to its network aspects.
  • Error definition and handling
  • Response times
  • Intended operating environment
  • Safety-related requirements derived from a risk assessment
  • Regulatory requirements
  • User maintenance requirements

 

Traceability

  • Should trace all the SRS to SDS, Test Case IDs (at each level of testing), Software Version and release, Risk Assessment IDs.

 

System and Software Architecture Diagram
The roadmap of the device design should include:

  • The modules and layers that make up the system and software.
  • The relationships among the modules and layers.
  • The data inputs/outputs and flow of data among the modules and layers
  • How users or external products, including IT infrastructure and peripherals (e.g., wirelessly connected medical devices) interact with the system and software.
  • The software architecture diagram may comprise multiple static diagrams, dynamic diagrams, and cybersecurity architecture diagrams to convey the information clearly to facilitate the review process. If more than one diagram is used, the sponsor should provide a high-level diagram that communicates the overview and points to other diagrams, and the relationship between diagrams.
  • For multiple-function device products, the system and software architecture diagram should delineate between the device functions under review and the “other functions.”

 

Software Design Specification (SDS)

 

Basic Documentation Level
SDS not required as part of the premarket submission. Sponsors should document this information on the design internally via the DHF for the device.

 

Enhanced Documentation Level

  • Technical design details of how the software functions, how the software design completely and correctly implements all the requirements of the SRS, and how the software design traces to the SRS in terms of intended use, functionality, safety, and effectiveness.
  • Software functional units or modules and the interfaces identified in the architectural (i.e., high-level) design should be documented with the corresponding detailed (i.e., low-level) design information in the SDS.

 

Software Development, Configuration Management, and Maintenance Practices
Basic Documentation Level

The summary information should include the following:

  • Processes and procedures used in software development, verification and validation.
  • Standards (e.g., coding), methods and tools used in software development.
  • Main deliverables of the typical activities and tasks involved in software development, verification and validation.
  • Processes, procedures, and tools used to link user needs, system requirements, software requirements, software design specifications, software testing and implemented risk control measures (i.e., traceability).
  • Processes and procedures used in software configuration and change management.
  • Processes and procedures used in software maintenance that include risk assessment of software changes, initial testing that evaluates the correctness of the implemented software change(s) and regression analysis and testing.

 

Enhanced Documentation Level
Documents implementing the configuration management and maintenance plans should be provided in addition to the summary documentation requested for the Basic Documentation Level.

Or
Compliance to IEC 62304 Software Life cycle

 

Software Testing as part of Verification and Validation

 

Basic Documentation Level

    • A summary description of the testing activities at the unit, integration, and system levels. The summary description should include the software version tested and the overall pass/fail test results for all test protocols (i.e., collection of test procedures for specific software functionality) executed. If the device is a modified version of a previously cleared or approved device, provide a summary of the modifications compared with the previously cleared or approved version.
    • Any intentional changes made in response to failed tests and documentation of test results demonstrating that the intentional changes were implemented correctly.
    • A regression analysis and pass/fail test results to account for unintended effects of a software change.
    • System-level test protocol including expected results derived from software requirements, actual results that are observed and recorded, objective pass/fail determination, and a system-level test report. The system-level test report should demonstrate that the protocol has been acceptably executed with passing test results and that any unresolved anomalies have been acceptably deferred based on a risk assessment for the candidate release version.

 

Enhanced Documentation Level
In addition to the documentation requested for the Basic Documentation Level, Unit level, Integration level, and System level test protocols and reports should be provided including expected results derived from software requirements and design, actual results that are observed and recorded, and objective pass/fail determination.

 

Software Version History
Revision history tabulating the major changes to the software during the development cycle, including date, version number, a brief description of the changes relative to the previous version, and an indication of the version on which testing was performed.

 

Unresolved Software Anomalies
A list of unresolved anomalies should document the following items (e.g., in tabular format) for each unresolved anomaly present in the software:

  • A description of the anomaly.
  • Identification of how the anomaly was discovered and, where possible, identification of the root cause(s) of the anomaly.
  • Evaluation of the impact of the anomaly on the device’s safety and effectiveness, including operator usage and human factors considerations.
  • Outcome of the evaluation; and
  • Risk-based rationale for not correcting or fixing the anomaly in alignment with the sponsor’s risk management plan or procedure(s).

 

Refer to the FDA’s guidance on software in medical devices and utilize IEC 62304, a recognized standard that outlines the medical device software lifecycle, incorporating a risk-based approach.

Section 17 Electromagnetic Compatibility and Electrical Safety (Not applicable for non-active devices)
 

 

Assess and document how your device interacts with other electronic devices. This includes ensuring it does not cause or get affected by electromagnetic interference. Use IEC 60601-1-2 as a reference for EMC requirements and testing.

 

If your device has electrically powered components that are in patient contact, demonstrate their safety. Refer to IEC 60601-1 for general safety requirements, along with its amendments, to ensure compliance with safety standards.

  1. EMC related Device characteristics and Intended use environments:
    Overview of devices, their functions and modes with diagrams
    Description of Power supply and wireless technology used
    Description of intentional RF emitters

Statement of Intended Use Environment

  1. Risk Assessment of Medical Device

 

Device design & Test level determination by consensus standards
Non-implantable Medical Devices
The ANSI/AAMI/IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard:  Electromagnetic disturbances – Requirements and tests is a collateral standard to the ANSI/AAMI ES 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance standard

 

Active implantable Medical Devices (AIMDs)
ISO 14117 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices and the ISO 14708 series.

 

Special Environments
Additional EMC testing required referring to the specific environmental use along with ISO 60601-1-2 (Home and Professional healthcare facility environmental use).

  1. Essential performance and Immunity Pass/Fail Criteria
    Essential Performance: Performance can be determined by identifying the performance of the clinical function specifying performance limits for fully functional performance versus loss or degradation of the identified performance evaluating the risk from loss, degradation, disruption, deviation, or over-delivery of the performance.

 

General guidance and rationale” of ANSI/AAMI ES 60601-1 and Clause 2.3.4 of AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
Immunity Pass/Fail Criteria:
Detailed with specifications related to

  1. Quantitative
  2. specific to the medical device and functions, and
  3. observable.

 

These criteria should be determined based on the medical device’s functions, modes, indications for use, intended use, and Essential Performance (if applicable).

  1. Medical Device Configuration and Functions Tested
  1. A detailed description of the medical device under test, including the configuration, functions, modes, and settings that were tested.
  2. The description of the device under test should include the medical device name, model number, manufacturer, and an indication of whether the device is the final production-ready medical device currently under review.
  3. If testing not performed on Final Finished device provide scientific justification or explanation how the test results are applicable to finished final product.

 

  1. Results of EMC Testing
  1. Summary on the Information of the medical device emissions and the immunity to EM disturbances at test levels appropriate for the medical device’s intended use environments
  2. Summary on the results of Emission tests with pass/fail criteria expressed with limits.
  3. Summary of results of immunity tests (Should include degradation that were observed both during and after immunity test for continuous phenomena and after immunity test for transient phenomenon).

 

  1. Modifications

Medical Device modifications to meet or pass EMC test, as a result of EMC test failure should be described with analysis.

 

  1. Device Image
Section 18 Performance Testing – Bench
 

This section typically encompasses the majority of your design verification and validation testing. It should include a comprehensive account of the bench testing conducted on your device.
Include detailed protocols, results, analysis, and conclusions from these tests. Bench testing often forms a significant portion of the evidence for your device’s performance.

Test report summaries including the following element.

  1. List of Testing being performed.
  2. Objective of the Tests
  3. Brief description of the test methods, including sample size, devices tested, and consensus standards utilized.
  4. Pre-Defined Pass/Fail Criteria
  5. Results Summary (Quantitative or Qualitative)
  6. Data analysis Plan
  7. Protocol Deviation(s) if any exists.
  8. Discussion / conclusions
Section 19 Performance Testing – Animal
 

 

Not all devices require animal testing. If it’s relevant for your device, ensure you follow FDA guidance and potentially engage in a pre-submission process for feedback. Reference applicable guidance documents to understand specific animal testing requirements for your device category.

Test Report

  1. Overview of the purpose of the animal testing and explanation
  2. list the specific animal tests conducted.
  3. description each test protocol.
  4. Results summary.
  5. description of analysis; and
  6. Conclusions.

 

Test Protocol

  1. objective of the test.
  2. test articles used in the test.
  3. test methods and procedures (including any specific test conditions);
  4. study endpoint, i.e., the specific parameter measured; and
  5. pre-defined acceptance or pass/fail criteria.

 

Location of complete test report should be clearly marked in 510k submission file.

Section 20 Performance Testing – Clinical
 

 

 

The FDA will consider alternatives to clinical studies if supported by adequate scientific rationale. If clinical testing is necessary, determine whether your study is of significant or non-significant risk, complying with the relevant FDA regulations (21 CFR Parts 50, 56, and 812).

 

Test Protocol

  1. objective of the test.
  2. test methods and procedures (including any specific test conditions);
  3. study endpoints (usually both safety and effectiveness); and
  4. statistical methodology used.

 

Test Report

  1. Overview of the purpose of the clinical testing in comparison to the intended use, indications for use, environmental conditions, risk assessment.
  2. List of tests to be conducted
  3. Description of each test protocols
  4. Summary of Results
  5. Description of Analysis
  6. Conclusion

We offer the best guidance and solutions for 510k submission to worldwide manufacturers and specification developers. Our services are time-bound and economical. We match prices. So partner with us and experience the difference firsthand.

Frequently Asked Questions

How should I prepare my 510k submission?

Preparation involves guidance document understanding, gathering all required documentation (Technical, manufacturing) conducting necessary testing, and ensuring that the 510k file meets all regulatory requirements. Engaging with a 510k regulatory consultant like I3CGLOBAL can help ensure a complete, compliant and fast submission.

Where and whom to submit 510k Q-submission?

You must submit an eCopy of your Q 510k submission under section 745(A)(b) of the FD&C Act. An electronic copy (eCopy) is an electronic version of your medical device submission stored on a compact disc (CD), digital video disc (DVD), or flash drive. Use the eCopy Validation Module to ensures your eCopy is formatted correctly. You must attach a paper copy of your company covers letter (including a signature) to the eCopy (CD, DVD, or flash drive).

 

A medical device submission package should be sent to the CDRH Document Control Center (DCC) at the following address:

 

U.S. Food and Drug Administration

Center for Devices and Radiological Health, Document Control Center (DCC) – WO66-G609, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002

What is Performance testing and Bench testing? How could help in faster 510k clearance

Performance data should be provided to help demonstrate the SE of your device to predicate the device. The data may include test results from engineering, bench, design verification, human factors, animal testing, and clinical studies and clinical trials. Tests should be conducted on all sizes and models of the device.

 

FDA classifies non-clinical performance testing under bench testing. These tests are performed by either a device manufacturer or a third-party testing facility (e.g., test laboratory), which includes all bench testing and will depend on the specifics of the actual device or device type. Non-clinical bench performance testing includes tests to evaluate mechanical and biological engineering performance (e.g., fatigue, wear, tensile strength, compression, etc).

 

The reviewer will require test report summaries, test protocols, and test reports. The test report summary ideally includes a brief description and summary of the various tests performed as part of bench testing. The complete test reports also should be included as part of the premarket 510k submission. Test protocols contain the testing methods, test objective, acceptance criteria, and data analysis plan. The contents of the test protocol can also be included as part of the test report and submitted as a single document.

How long the Q 510k submission process?

75-90 days (*21 days for urgent public health issues)

Day 1                  Review Team

Day 5                 Acknowledgement

Day 15               Acceptance Review

Day 30 – 40     Meetings Scheduled if needed

Day 70              FDA Feedback

Day 75              Meeting

Day 90             Meeting Minutes from Submitter

Day 120            FDA revisions to the meeting, if needed

 

If FDA determines that the information provided is insufficient, the request will be refused to accept, or RTA and the sponsor should provide the additional information, which will be logged in as an amendment to the Q-Submission

Can a applicant withdraw a 510k submission?

Yes, an applicant can withdraw a 510k at any time before the FDA makes a final determination. The review fee paid should collect back in 60 days.

How much is the total cost for a 510k submission?

The following are the fee for a submission (standard and small business)

  • FDA Review Fee
  • Documentation and US Agent Fee
  • Biocompatibility / Electrical Safety (if applicable)
  • Performance tests
  • Validations
  • Shelf life / lifetime etc.

What happens if my 510(k) submission is not accepted?

If the FDA does not accept a submission (Refuse to accept / RTA) they will provide feedback explaining the deficiencies. The applicant can address this issues / missing information and resubmit the application.

How long does the 510k submission and review process will take?

The file preparation takes 4-5 months

The FDA generally targets to review and make a determination on a submission within 90 calendar days. However, the timeline may fluctuate based on the complexity of the device and the quality of the submission.

Any specific restrictions on the file size for a 510k submission to the FDA?

There are no specific restrictions on the file size for a submission to the FDA, but there are practical considerations to keep in mind.

 

All 510k submission must be made electronically through the FDA’s Electronic Submission Gateway (ESG). While there isn’t a strict file size limit, large files can take longer to upload, and there may be technical challenges related to very large submissions.

Any specific file structure for a 510k submission?

The 510k submission should be well-organized, typically divided into multiple files or sections. This not only makes it easier to upload but also helps the reviewers navigate the document efficiently. Common practice is to break down the submission into different sections.

Any practical tips regarding 510k submission file upload

Compressing files where possible (e.g., optimizing PDFs) can help manage overall submission size. Always check the final 510k submission files to ensure they meet the FDA’s requirements, including ensuring that all links work, files are readable, and the submission is complete.