Summary of FDA requirements for 510(k) applications

General suggestions

The FDA recommends that your FDA submission follow the Traditional 510(k) format provided in the FDA guidance document: "Format for Traditional and Abbreviated 510(k)s". The 510(k) should consist of 21 different sections, along with any relevant test reports. 


It is common to create a separate WORD document for each 510(k) section, and then convert it to a PDF. Alternatively, you can write all 21 sections of the 510(k) in a single WORD document.


Make sure that your eCopy PDF does not have a password, embedded attachments, or other special attributes. 


Include the number for each page in the 510(k). Numbering pages by section is preferred. For example, the pages in Section 1 could be numbered as 1-1, 1-2, 1-3, etc. While the pages in Section 2 can then be numbered 2-1, 2-2, 2-3, etc. Appendix A could be numbered as A-1. A-2, A-3, etc. 



Table of Contents

Include a “Table of Contents” at the beginning of your 510(k) that clearly identifies each section title and corresponding page number in the 510(k). For example:

• “Section 5 – 510(k) Summary – Page # 5-1”


The table of contents should also include a list of any attached appendices. For example:

• Appendix A – Instruction for Use – Page # A-1”

• Appendix B – IEC 60601-1 test report – Page # B-1



Section 1 - Medical Device User Fee Cover Sheet

Do not include this Form, because the FDA waives any 510(k) application fees when you use a Third-Party Review service. Just write that “this Form is not necessary”. See here for more information: https://www.fda.gov/medical-devices/510k-third-party-review-program/how-submit-510k-through-third-party-review-program



Section 2 - CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)

Click here to download and fill out this form (you may have to use Internet Explorer to open the PDF): https://www.fda.gov/media/72421/download


For the "Type of Submission" on page 1 of Form 3514, place a checkmark next to “Third Party”.


Make sure to include the registration number, name, and address of each facility used to manufacture your device – including contract sterilizers and packagers.


On page 3 of Form 3514, you must write the 510(k) number of any prior related submissions (including for previously withdrawn 510(k) applications on the same device).


You will not be able to combine this PDF directly to the eCopy PDF, because it has a security feature. Therefore, print it out and scan it. Then attach the scanned copy to the eCopy PDF.



Section 3 - 510(k) Cover Letter & RTA Checklist 

See Appendix A in FDA´s guidance on the “Format for Traditional and Abbreviated 510(k)s” for more information on the suggested content of your 510(k) Cover Letter: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-510ks-guidance-industry-and-fda-staff


• Make sure to include the following text in your cover letter: “The eCopy is an exact duplicate of the paper copy.”.


• Make sure to sign and date your cover letter.


Fill out all of the relevant parts of the following “Refuse to Accept” (RTA) document, including the page numbers in your 510(k) to identify the location of the requested items. Print out pages 19 to 30 of this weblink: https://www.fda.gov/media/83888/download


You will not be able to attach these PDFs directly to the single (eCopy) PDF. Therefore, print them out and scan them.



Section 4 - Indications for Use Statement (FDA FORM 3881)

Click here to download and fill out this form (you may have to use Internet Explorer to open the PDF): https://www.fda.gov/media/86323/download


The “indications for use” of the device, includes the following: (a) the general description of the diseases; or (b) conditions that the device will diagnose, treat, prevent, cure, or mitigate. Also, include a description of the patient population for which the device is intended (e.g., “Adults only”; or “Pediatric & Adults”). 


Make sure that you use the same exact wording of your Indications for Use statement throughout the 510(k) application, such as the User´s Manual.


You will not be able to attach this PDF directly to the single (eCopy) PDF. Therefore, print it out and scan it.



Section 5 - 510(k) Summary

The 510(k) summary must contain the information described below. Please note that a model template for the 510(k) Summary can be found in Appendix C of the following FDA guidance: https://www.fda.gov/media/82395/download


1. Write the term “510(k) Summary” at the top of the first page of this section. 


2. The 510(k) summary contains on the first page the following information: the 510(k) owner's name, address, phone and fax numbers, name of contact person, and date when the 510(k) Summary was prepared.


3. The 510(k) summary includes the name of the device, including the trade or proprietary name, the common or usual name, and the classification name. For example:

• Trade name - DRAG@N LATEX EXAMINATION GLOVES

• Common name - Exam gloves

• Classification name - patient examination glove (21 CFR 880.6250, Product Code FMC)


4. The 510(k) summary identifies the predicate device to which your firm is claiming equivalence.


5. Find out if the predicate device has been the subject of a recall -- search here for all FDA recalls: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

If it has not been in a recall, then write the following sentence below the name of the predicate device: “This predicate has not been subject to a design-related recall.


6. The 510(k) summary includes a description of the device such as might be found in the labeling or promotional material for the device including the following:

• An explanation of how the device functions,

• The scientific concepts that form the basis for the device, and 

• The significant physical and performance characteristics of the device (such as device design, material used, and physical properties).


7. The 510(k) summary provides the “indications for use” of the device, including (a) the general description of the diseases or (b) conditions that the device will diagnose, treat, prevent, cure, or mitigate. Including a description of the patient population for which the device is intended.


8. If the “Indication for Use” statement is different from those of the predicate device, then the 510(k) summary shall contain an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device. In addition, describe why the differences do not affect the safety and effectiveness of the device when used as labeled.


9. The 510(k) summary contains a summary of the technological characteristics of your device compared to the predicate device. If the device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device, then a summary of the technological characteristics of the new device in comparison to those of the predicate device should be included. If your device has different technological characteristics from the predicate device, then provide a summary of “how” the technological characteristics of your device compare to the predicate device.


10. If the determination of substantial equivalence is also based on an assessment of non-clinical bench performance data (e.g., ISO or IEC test reports), then include a brief discussion of the non-clinical bench tests submitted, referenced, or relied on in the 510(k) submission for a determination of substantial equivalence. Describe how their results support a determination of substantial equivalence.


11. The summary includes the conclusions drawn from the non-clinical bench tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.


12. The 510(k) summary includes only information that is already covered in the body of the 510(k) application.


13. The 510(k) summary does not contain any marketing exaggerations or unsubstantiated marketing claims.




Section 6 - Truthful and Accuracy Statement 

The 510(k) applicant must copy and sign the following statement (you may have to use Internet Explorer to open the PDF):

https://www.fda.gov/medical-devices/premarket-notification-510k/premarket-notification-truthful-and-accurate-statement

You will not be able to attach this PDF directly to the single (eCopy) PDF. Therefore, print it out and scan it.



Section 7 - Class III Summary and Certification 

This is not applicable for your 510(k).



Section 8 - Financial Certification or Disclosure Statement

This is only applicable if you performed a clinical study.



Section 9 - Declarations of Conformity and Test Summary Reports

The FDA expects that all necessary testing required by the relevant consensus standard(s) will be performed, and conformance to the consensus standard will be met prior to sending the 510(k) submission. To certify compliance with a consensus standard, you must submit a Declaration of Conformity (“DoC”), which consists of the following 8 elements. The FDA provides an example of a proper Declaration of Conformity on page 15 of their presentation: https://www.fda.gov/media/117223/download


a. Name and address of the applicant/sponsor responsible for the DoC;

b. Product/device identification, including product codes, device marketing name, model number, and any other unique product identification data specific to the DoC in question;

c. Statement of Conformity;

d. A list of standards for which the DoC applies including, for each standard, the options selected, if any;

e. The FDA recognition number for each standard;

f. The date and place of issuance of the DoC;

g. A signature, printed name, and function of the sponsor responsible for the DoC; and

h. Any limitation on the validity of the DoC (e.g., how long the declaration is valid, what was tested, or concessions made about the testing outcomes). Describe whether there have been any deviations made to the consensus standard(s) identified. For example, provide a reason for every clause in the consensus standard, where you believe that it does not apply to your device.


Read here for more information on Declarations of Conformity: 

• “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices” - https://www.fda.gov/media/71983/download

• “Required Elements for a Declaration of Conformity to a Recognized Standard” - https://www.fda.gov/medical-devices/premarket-notification-510k/required-elements-declaration-conformity-recognized-standard




Section 10 - Executive Summary 

Provide a “test report summary” for each non-clinical bench test in the 510(k) application, which briefly describes & summarizes the testing performed to support the 510(k) submission. Each bench test “report summary” must use the format specified on pages 5 to 7 of the following FDA guidance:  https://www.fda.gov/media/113230/download



Section 11 - Device Description

This section should include both (1) a narrative description of the device and (2) a physical or technical description. 


The narrative description of your device must include the indications for use, principles of operation, power source, and other information necessary to understand the device. 


The physical description of your device must include labeled diagrams, photographs/pictures, engineering drawings, schematics, etc. Include all internal & external, assembled & unassembled, and interchangeable parts of the device. These documents must describe the name and function of all critical parts. In addition, include the length, width, height, diameter, weight, etc., of the device. Lastly, identify any parts that are intended for single-use.


List all key device components and accessories included in the 510(k) submission (e.g., catheter, cable wire, leads. etc.). If the 510(k) is for an accessory or component that would be sold to an end-user, then describe a typical device with which the accessory or component will be used. 


List all the variations of your device that you intend to market (including all model or version numbers) and briefly explain the differences among the different models or versions. 


Describe the critical performance specifications of your device, and include a brief description of the device design requirements in this section. 


Provide a written description of the Device in terms of the following (address all that apply):

• Explanation of how the device works/principle of operation

• Mechanism of action

• Any necessary feature to determine substantial equivalence or device performance

• Energy source 


Device Characteristics can include the following (address all that apply):

• software

• any patient-contacting materials

• coatings

• additives

• single-use

• sterile

• sterilization method [specify]


Environment of Use (address all that apply):

• healthcare facility/hospital

• home

• other (for example: transport ambulances)


Materials of Use (address all that apply):

• General type of material used (e.g., polysulfone, stainless steel, etc.)

• If a material conforms to an FDA recognized consensus standard for medical use, include the applicable number (e.g., ASTM FXXXX-last 2 digits of the year)

• Duration and type of contact with the patient


Include all the diagrams, dimensions, tolerances, and/or schematics that are necessary for the 510(k) Reviewer to understand your device, accessory, or component.


Provide a list of all patient contacting components and their respective materials. If they have previously included in a 510(k), then write the 510(k) number next to the accessory or component.


Make sure to identify (with a title & number) all tables, charts, diagrams, drawings, figures, illustrations, or photos that are used. Make sure that citations in the text refer to them correctly.


If your device is connected to other devices, in which information is exchanged and used across the connections, then include the requirements in the following guidances: https://www.fda.gov/media/95636/download




Section 12 - Substantial Equivalence Discussion (comparison to predicate Indications)

Create a side-by-side comparison table that includes your device and the predicate device. Include a column where you discuss the similarities and differences of your device, as compared to the predicate device to which you are claiming substantial equivalency. It must be shown that technological differences do not adversely affect safety and effectiveness. You must justify the differences with the predicate device by using supportive evidence and data.


It is often necessary to have a physical copy of the predicate device in order to perform comparison testing to show substantial equivalence.


You can also use a copy of the predicate device´s Instructions for Use to show that your device is substantially equivalent to certain features of the predicate device.  


Substantial equivalence is to be established with respect, but not limited to, intended use, design, energy used/delivered, materials, performance, safety, effectiveness, labeling and other applicable characteristics, such as sterility.


In the substantial equivalence section, you must identify the predicate and identify its trade name, model number, 510(k) submitter/holder, and 510(k) number. 


Provide a detailed comparison between your device and the predicate device in terms of (as applicable):


• Indications for Use;

• Target population (e.g., All patients, Adults only, etc.);

• Environment of Use (e.g., hospital, home, or ambulance);

• Usability/Human factors testing;

• Performance; 

• Materials;

• Compatibility/interoperability with other devices;

• Electrical safety,

• Anatomical site;

• Energy used/delivered;

• Design;

• Technology; 

• Safety features;

• Effectiveness; 

• Labeling;

• Sterility;

• ISO, IEC, or ANSI/AAMI standards met;

• Biocompatibility;

• Sterility;

• Mechanical safety; and

• Thermal protection.


For additional background on making determinations of substantial equivalence, FDA recommends that you refer to the following FDA guidance document: https://www.fda.gov/media/82395/download




Section 13 - Proposed Labeling 

Include the final drafts of your Instructions for Use, labels, labeling, package inserts, service manuals, advertising, and brochures. 


The Instructions for Use (i.e., User´s Manual) must include a specific “Indications for Use” statement (with the same wording as in section 4 of the 510(k) application), along with any relevant warnings, cautions, contraindications, or limitations. 


A copy of the Instructions for Use and labeling for the predicate device is recommended by the FDA. Further labeling guidance is provided in the weblinks below:

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/device-labeling-guidance-g91-1-blue-book-memo




Section 14 - Cleaning, Reprocessing, Sterilization, and Shelf Life

If your device is reusable, then your Instructions for Use must include the reprocessing instructions. In addition to your validation test report on the cleaning instructions and disinfection/sterilization instructions. The reprocessing validation data should demonstrate that the proposed reprocessing instructions would reprocess your device, at least as well as the reprocessing instructions for the predicate device. 


Make sure that the full reprocessing or cleaning test report is included in the Appendix of the 510(k) application.


If your device is reusable, then your Instructions for Use must include the six criteria found in Section VI of the FDA´s reprocessing guidance: https://www.fda.gov/media/80265/download


Describe your device´s usability validation of the reprocessing instructions to ensure that the intended users will be able to understand and follow your device´s instructions. If the reprocessing instructions are too complicated or unclear, then the users may not be able to correctly clean and disinfect/sterilize your device.




Section 15 - Biocompatibility & Toxicological Assessments

As the FDA makes clear in their guidance, if your device makes any kind of contact with a patient, then it will need some biocompatibility testing - https://www.fda.gov/media/85865/download

Even if your device uses the same material as the predicate, your device´s manufacturing process, geometry, or duration of use may be different – which leads to a potential risk from a biocompatibility perspective.


Make sure that the full test reports are included in the Appendix of the 510(k) application. 


Include a “Table of the Biocompatibility Evaluation Information”, as described in “Attachment C” of the following FDA biocompatibility guidance: https://www.fda.gov/media/85865/download


All biocompatibility test reports should be conducted under GLP (“Good Laboratory Practice”) and must address the reporting requirements of 21 CFR 58. In addition, the contents of the biocompatibility test reports must follow “Attachment E” in the FDA biocompatibility guidance (e.g., identify any protocol deviations and their impact on the conclusions drawn from the test): https://www.fda.gov/media/85865/download


Pyrogenicity testing is required to reduce the risk of reactions from bacterial endotoxin for all implants, including devices that are intended to have contact with the cardiovascular system and lymphatic system (limit of 20 EU/device). Devices in contact with cerebrospinal fluid have a lower limit of 2.15 EU/device. These devices must also be labeled as “nonpyrogenic” in the labeling. Lastly, these devices must include an endotoxin batch release monitoring plan, which will include the testing from every product batch, for their applicable endotoxin levels (e.g., AAMI ST72:2011/(R)2016): https://www.fda.gov/media/83477/download


If you already have a previous 510(k) on your device and that is your predicate device, and there have been no changes in terms of materials and manufacturing methods since the last 510(k). Then you may be able to avoid biocompatibility testing on the revised version of your device by adding the following wording to your 510(k) application – for every patient-contacting material and component part:


  • "The [polymer/metal/ceramic/composite name] [component name] of the medical device in its final finished form is identical to the [component name] of the [name] (your previous 510(k) cleared device) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)."


If the above statement is true for all of the device component material formulations, processes, and sterilization methods (if applicable) in the subject device, then the following general statement can be provided in your 510(k) application if it applies to your device:


  • "The medical device in its final finished form is identical to [name] (your previously marketed device) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)."




Section 16 - Software & Cybersecurity

This section should include the appropriate software documentation as described in the FDA´s guidance for Software Contained in Medical Devices - https://www.fda.gov/media/73065/download

As discussed in this guidance, you must identify the “level of concern” (minor, moderate, or major) associated with your device and provide documentation consistent with that level.


Follow the FDA guidance on Cybersecurity: https://www.fda.gov/media/119933/download


The FDA recommends that medical device manufacturers apply the NIST Cybersecurity Framework to medical device security – including the “identify, protect, detect, respond, and recover security” functions. https://www.fda.gov/news-events/press-announcements/fda-outlines-cybersecurity-recommendations-medical-device-manufacturers

The NIST Framework for Improving Critical Infrastructure Cybersecurity can be found here:

https://www.nist.gov/sites/default/files/documents/cyberframework/cybersecurity-framework-021214.pdf




Section 17 - Electromagnetic Compatibility and Electrical Safety 

Include all of the information that is described on page 5 of the following EMC guidance: https://www.fda.gov/media/94758/download


Include all of the recommendations in section 4 of the FDA guidance on RF Wireless technology - https://www.fda.gov/media/71975/download


If your device has RF Wireless technology, provide a test report on the evaluation of wireless co-existence (see ANSI IEEE C63.27-2017): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=35809


The Federal Communications Commission (“FCC”) oversees the use of the public Radio Frequency (“RF”) spectrum in the USA, within which RF wireless technologies operate. The FDA’s policies on wireless medical devices are coordinated with the FCC. For more information on the requirements of the FDA over FCC-related issues, see here: https://www.fda.gov/medical-devices/digital-health/wireless-medical-devices

Applicants for a 510(k) can demonstrate that their device complies with the FCC requirements by following the FCC´s specifications (for example:  FCC CFR 47 Part 15, Subpart C). 




Section 18 - Performance Testing – Bench

Tests should be conducted on all sizes and models of your device in a manner as similar as possible to how the device will be used. The results of the testing, as well as the methodology & parameters used for testing, must be included. For example, in the case of electrical or EMC testing, the device must be turned on and operational. 


For accessories and components, you may have to connect them to another device to properly perform the testing. Any other medical devices that you include in the test for your new device, should already have a 510(k) clearance. For example, if your 510(k) is for an electrode, then you will have to attach it to an electrosurgical generator (which must be 510(k) cleared) for electrical tests. 


The FDA´s guidance on usability testing recommends that your usability report should discuss the safety-related usability considerations, issues, processes, resolutions, and conclusions. An example of the usability report´s structure is provided in Appendix A of the FDA´s guidance: https://www.fda.gov/media/80481/download


The FDA also recommends that you should conduct the usability testing on at least 15 healthcare professionals in the United States, although this is only definitely required for devices inside the FDA´s “List of Highest Priority Devices for Human Factors Review” (e.g., Duodenoscopes, Infusion pumps, Ventilators, etc.): https://www.fda.gov/media/95804/download

 

Because the FDA only recognizes the USA-specific version of IEC 60601-1:2005 (i.e., ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012), make sure that your device´s test house simultaneously tests to both IEC & the FDA recognized ANSI/AAMI standard for 60601-1. There are only a few clauses that are different, but it is essential that the electrical safety test report shows that the USA-specific clauses were met. See here for more information: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32316




Section 19 - Performance Testing – Animal

If you conduct animal testing, then describe the tests and provide the results that support the performance characteristics of your device. This is especially important for implantable devices. Frequently, medical devices that work as anticipated in an in vitro experiment, develop unforeseen problems when implanted in animals.


The FDA prefers that preclinical trials of medical devices in animals follow the requirements of the Good Laboratory Practices (GLP). Generally, all submissions that describe animal testing should include the information below; however, if a relevant device-specific guidance is available, you should follow the recommendations in that guidance document. 


• list the specific animal tests conducted 

• describe each test protocol 

• summarize the results 

• explain your analysis 

• discuss your conclusions




Section 20 - Performance Testing – Clinical

All submissions that describe clinical studies on humans should include the information below; however, if a relevant device-specific guidance is available, you should follow the recommendations in that guidance document. 


If your submission describes clinical studies on humans, then provide the clinical protocol that identifies the following:


• the objective of the test

• test methods and procedures (including any specific test conditions)

• study endpoints (usually both safety and effectiveness)

• statistical methodology used.


In addition, discuss the study results, analyses performed (including statistical, as appropriate), and conclusions. Also, discuss any comparison testing with the predicate device in terms of substantial equivalence.




Section 21 - Other 

Previously withdrawn 510(k) info, Real World Evidence, etc.




Appendix 

It is common practice to include longer documents in an Appendix. For most 510(k) applications, the majority of pages will be located in the Appendix.


For example, if the “Instructions for Use” document is too large to place in section 13, then it can be placed here as Appendix A.


You can also place in the Appendix the following types of documents:


• Full ISO and/or IEC test reports (e.g., electrical safety, EMC, etc.);

• Biocompatibility full test reports (e.g., ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization & Irritation));

• Risk management report (e.g., ISO 14971);

• Usability / Human Factors test report (e.g., FDA guidance, IEC 60601-1-6, AAMI/ANSI HE75, IEC 62366-1);

• Reprocessing/Cleaning validation test report (e.g., ISO 17664, AAMI TIR 30, AAMI TIR12);

• Sterilization validation test report (e.g., ISO 11135, ISO 11607, EO residuals);

• Stability/Shelf life test report (e.g., Effect of accelerated aging on seal strength, leakage, appearance, etc.);

• Software validation test reports (e.g., IEC 62304);

• Effect of transportation on the packaging (e.g., ISTA 2A), and

• Device-specific verification/validation test reports (e.g., mechanical, electrical, and biological engineering performance – such as fatigue, wear, tensile strength, compression, flow rate, burst pressure, etc.).




For more information on the 510(k) format, please read the following FDA documents:


Format for Traditional  510(k)s: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-510ks-guidance-industry-and-fda-staff


How to Prepare a Traditional 510(k): https://www.fda.gov/medical-devices/premarket-notification-510k/how-prepare-traditional-510k


510(k) Format Tips: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-format-tips


Content of a 510(k): https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k


Evaluating Substantial Equivalence in Premarket Notifications:  https://www.fda.gov/media/82395/download


The 510(k) Program – PowerPoint slides: https://www.fda.gov/media/94060/download


CDRH Learn Webinar: http://fda.yorkcast.com/webcast/Play/7a8fa9b887004ff2b2b72d4035e3916c


You can find the 510(k) Summary of your predicate device by going to the FDA’s database for 510(k) Summaries: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm


If you don’t know your device’s product code, then you can type in the “common name”, using general terms, for your device on the FDA’s database for Product Code classification: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

 

Combine all of your individual PDFs into a single PDF; this amalgamated PDF will be known as the “eCopy PDF”. See https://www.fda.gov/media/83522/download for more information on the eCopy requirements by the FDA.