- General Information
- Table of Contents (recommended)
- 510(k) Acceptance Checklist (recommended)
- Statement of Indications for Use
- 510(k) Statement or Summary
- Truthful and Accuracy Statement
- Proposed Labeling
- Substantial Equivalence Comparison
- Additional requirements, as appropriate
The 510(k) regulation is found in 21 CFR 807 Subpart E and includes information required in a 510(k). The 510(k) is not a form. The information should be provided in an organized, tabulated document. The 510(k) should provide sufficient detail for FDA to be able to determine that the device is substantially equivalent (SE) to another similar legally marketed device(s). Some sections will contain only one page; others may contain 50 or more pages. The average 510(k) is about 35 pages; others may run to 100 or more depending on the complexity of the device. For any device, the 510(k) is formatted essentially the same way and contains the same basic information (required elements).
The 510(k) submitter should prepare and submit a complete application in order to obtain marketing clearance. To facilitate FDA review of the data, analysis, and conclusions in the application, the manufacturer should check for the:
- logical presentation of the data;
- scientific soundness of the test and data analysis;
- relevance of the test program to the device and the intended use; and
- completeness of the summary report of the tests or studies.
A description of the tests and the results obtained are essential. Reasonable and sufficient details of all test procedures and results should be submitted to FDA. The following suggestions will help assure that your application is complete.
- Understand the FDA decision-making process. The decision process is discussed in The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)]
- Obtain and use the right guidance. FDA provides many device specific guidance documents for the preparation of marketing applications.
- Use the CDRH Premarket Review Submission Cover Sheet and the Screening Checklist for all Premarket Notification 510(k) Submissions to prepare your submission. The cover sheet is a "fill-in-the-blank" format which satisfies many of the 510(k) requirements. The checklist will assure that all required elements are provided.
Important Note: In order to address the required elements, you will need the following information to assure that your 510(k) is complete. If you do not have this information, you should obtain it prior to proceeding.
- Classification of your device
- Predicate device(s)
- Final draft labeling
- Specifications including engineering drawings, photos, etc.
- Performance data such as bench, animal, or clinical testing (if applicable)
- Sterilization information (if applicable)
- Guidance document(s) specific to your device type, if it exists
It is not a requirement that you organize your 510(k) into the following labeled sections, you may make modifications in order to meet the specific needs of your device. The following is a brief discussion of the required elements.
Medical Device User Fee Cover Sheet (Form FDA 3601)
The first page of a 510(k) should be a printed copy of the Medical Device User Fee Cover Sheet (Form FDA 3601). The Medical Device User Fee Cover Sheet and instructions are available online.
CDRH Premarket Review Submission Cover Sheet
A cover letter and/or the CDRH Premarket Review Submission Cover Sheet should follow the User Fee Cover Sheet. If you choose NOT to use the CDRH Premarket Review Submission Cover Sheet, the cover letter should include all the elements contained in the coversheet. The use of the 510(k) coversheet may help expedite the processing of your 510(k).
You may use a cover letter to provide the information covered on the CDRH Premarket Review Submission Cover Sheet or provide this information elsewhere in the 510(k). The information provided should include the following.
- Submission date (month/day/year) and labeled as "510(k) Submission." The submission must be clearly identified as a 510(k) submission for accurate processing by the Document Mail Room staff. Identify the submission as a Traditional, Special, or Abbreviated 510(k).
- Submitter name, address, phone, fax and e-mail address. If the person who intends to market the device uses a consultant or another party to prepare the 510(k), the 510(k) submission should specify who the 510(k) owner is and who the preparer is. The 510(k) owner is the individual or firm that has legal authority to the device. Identify the person FDA should contact during the review process. A delay may occur if the FDA is not sure who to contact for additional information.
- Your establishment registration number. Although not a required part of the 510(k), firms (domestic and foreign) will need to register within 30 days of marketing the device or prior to importing the device. It is sufficient to state that you will register following FDA clearance. See Establishment Registration for additional information.
- The common name of the device. The common name is the name of the device as it is commonly known e.g., syringe, hip implant.
- The trade name (proprietary name) including the model number(s) of the device. The trade name is the name under which the device will be marketed.
- The classification name for the device and the class in which the device has been placed. The classification name is the generic category the device has been placed. Reference the classification regulation and the three letter product code. If you determine that the device is an unclassified device (a pre-amendments device for which a classification regulation has not been published), include a statement of that fact. For example, "To my knowledge, this device is an unclassified device. The product code of xxx has been assigned to this device in the Classification Database." If known, include the appropriate classification panel such as anesthesiology, orthopedic, etc. For additional information regarding product codes, please refer to the guidance titled “Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff.” For additional information regarding device classification, please refer to the guidance titled “FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act.”
- The reason for the 510(k). For example, it is a new device (i.e., you have never marketed the device in the U.S.) or a modification to an existing device. If the 510(k) is for a modification, describe in detail the reason for the modification. Provide the 510(k) number (if applicable) for the original device, and 510(k) number(s) for previous related submissions regardless of outcome. If you previously submitted a 510(k) that was withdrawn or found Not Substantially Equivalent, include those 510(k) numbers. If your modified device is based on a preamendments device, i.e., one marketed before May 28, 1976 which did not require a 510(k), state that no 510(k) number exists for the original device. State if the device is an accessory or finished component. A finished component is sold to the end user while an unfinished component cannot be used by the end user until further manufacturing steps occur, such as sterilization. Finished components are packaged and labeled for use and are for general sale while unfinished components are usually only sold to other device manufacturers for inclusion in another medical device.
- Identification of the legally marketed device (predicate) to which you claim SE. If known, provide the 510(k) number for the predicate device, trade name and product code.
- If applicable, include the registration number, name and address of each facility used to manufacture the finished device including contract sterilizers and packagers. The manufacturing process at each facility must be essentially the same and produce the same device as described in your 510(k) submission or state the differences.
- Compliance with any special controls [section 513(b) of the Food, Drug, and Cosmetic (FD&C) Act,] FDA mandatory performance standards (section 514 of the FD&C Act), standards under the Radiation Control for Health and Safety Act (RCHSA), or voluntary consensus standards. If no special controls, mandatory performance standards or radiation device standards exist for your product state, "No applicable mandatory performance standards or special controls exist for this device." If you are claiming substantial equivalence to one or more devices that meet a given standard, then your device should meet the same standard.
- Any required special controls for a device are provided in the regulation for the device under 21 CFR 800-892.
- Only one FDA mandatory performance standard exists for medical devices under section 514. Manufacturers of electrode lead wires and patient cables must conform to the standard set forth in 21 CFR 898.
- If your device emits ionizing, non-ionizing, sonic, or light radiation, performance standards may exist for the radiation emitting device under RCHSA.
Prepare a draft Table of Contents and update it as you prepare your 510(k). The table of contents should list each required item with page numbers, including a list of attachments and appendices. It is usually easier to number pages by section, e.g. 1.1, 1.2 (or use dashes, 1-1), 2.2, 2.3, etc. If additional pages need to be inserted into a section, it is easier to renumber that section than having to renumber all the pages that follow the inserted material if you used sequential numbering.
The 510(k) Acceptance Checklist is used to determine whether the 510(k) meets a minimum threshold of acceptability and should be accepted for substantive review. It is helpful to attach the 510(k) Acceptance Checklist following the Table of Contents. It should include page numbers where each of the elements in the 510(k) can be found. This will allow the FDA to easily find each required element. Second, by writing page numbers on the checklist, the 510(k) submitter may better ensure that the 510(k) is complete. The 510(k) may not be accepted for review if any of the required elements are not provided.
Prepare a Statement of Indications for Use as a separate page. We recomment that you use the Indications for Use form. The statement should include specific indications, clinical settings, define the target population, anatomical sites, etc. This statement must be consistent with your labeling, advertising and instructions for use. Once the review is complete, FDA will include the Indications for Use Statement with the Substantial Equivalence (SE) letter to the applicant and make it available to the public on the Internet.
Prepare either a 510(k) Summary or a 510(k) Statement. The Summary or Statement is required for all 510(k)s whether the device is Class I, II, or III. A 510(k) Summary is a summary of information upon which you based your claim of substantial equivalence. The 510(k) Statement is a certification that the 510(k) owner will provide safety and effectiveness information supporting the FDA finding of substantial equivalence to ANY person within 30 days of a written request.
A 510(k) Summary or 510(k) Statement must be included in your 510(k) submission in order for FDA to begin its scientific review of the 510(k) submission. The choice between the 510(k) Summary and 510(k) Statement should be made before the 510(k) is submitted. You may elect to change your choice between the summary or statement BEFORE the substantial equivalence determination is reached. However, after this determination is made, you cannot change your choice of a 510(k) Summary or 510(k) Statement.
Please ensure that whether you submit a 510(k) Summary as per 21 CFR 807.92, or a 510(k) Statement as per 21 CFR 807.93, it meets the content and format regulatory requirements.
If you choose to meet the conditions for a 510(k) summary (21 CFR 807.92), it must be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. As required by section 807.92(a), FDA will accept summaries or amended summaries until FDA issues a determination regarding substantial equivalence.
The 510(k) summary must contain the information described below. Please make a copy of the following to use as a checklist and check off each item to make sure your summary is adequate and complete.
For more information on the requirements of a 510(k) Summary, please refer to Section G of the guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)].
|[ ]||The summary should be in a separate section of the submission. It should begin on a new page and end on a page not shared with any other part of the 510(k) submission. It is clearly identified as "510(k) Summary" as required by section 807.92(c).|
|[ ]||The summary contains on the first page, preferably on your letterhead paper, the 510(k) owner's name, address, phone and fax numbers, name of contact person, and date the summary was prepared [807.92(a)(1)].|
The summary includes the name of the device, including the trade or proprietary name, if applicable, the common or usual name, and the classification name, if known [807.92(a)(2)].
|[ ]||The summary identifies the legally marketed device to which your firm is claiming equivalence [807.92(a)(3)].|
|[ ]||The summary includes a description of the device such as might be found in the labeling or promotional material for the device, including 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; [807.92(a)(4)].|
|[ ]||The summary provides the intended use of the device including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the predicate device, 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, and why the differences do not affect the safety and effectiveness of the device when used as labeled [807.92(a)(5)].|
|[ ]||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, 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, provide a summary of how the technological characteristics of your device compare to the predicate device. [807.92(a)(6)]|
|[ ]||If the determination of substantial equivalence is also based on an assessment of non-clinical performance data, the summary includes a brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence and how their results support a determination of substantial equivalence [807.92(b)(1)].|
|[ ]||If the determination of substantial equivalence is also based on an assessment of clinical performance data, the summary includes a brief discussion of clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence and how their results support a determination of substantial equivalence. This discussion shall include, where applicable, a description of the subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific reference to adverse effects and complications, and any other information from the clinical testing relevant to a determination of substantial equivalence [807.92(b)(2)]. Please note: Clinical data is not needed for most devices cleared by the 510(k) process.|
|[ ]||The summary includes the conclusions drawn from the nonclinical and clinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device . 807.92(b)(3)|
|[ ]||The summary includes any other information reasonably deemed necessary by FDA. Such requests will be made directly to the applicant by FDA or the requirements will be published in guidance documents. Additional information requested by FDA during review of the 510(k) may include additional safety and effectiveness information which may necessitate an update of your summary if requested by FDA. 807.92(d)|
|[ ]||Please make sure you have included all of the information listed above and verify that the following criteria have been met.
FDA will place the summary on the Internet 30 days following the substantial equivalent decision.
If you choose to submit a 510(k) Statement, the regulation requires the specific statement as provided in 21 CFR 807.93. The statement should be clearly identified as "510(k) Statement" and must be signed by the certifier, not a consultant to the 510(k) submitter.
For a new submission, leave the space for the 510(k) number blank. You will receive your 510(k) number in your 510(k) acknowledgment letter. The 510(k) document control number begins with the letter K followed by 6 digits.
If you elect to prepare a signed 510(k) Statement, anyone may request a copy of the 510(k) [with patient identifiers, trade secret and confidential information deleted] from the applicant of record. These written requests must be filled within 30 days. 510(k) owner's may not charge requesters for compiling and disseminating this data. Noncompliance with the 510(k) statement will be deemed a prohibited act under section 301(p) of the FD&C Act and FDA may choose to use its enforcement powers to obtain compliance.
All 510(k) submitters must include a statement certifying that all information submitted in the 510(k) is truthful and accurate and that no material fact has been omitted. The statement may be included in the 510(k) Cover Letter or may be on a separate page identified in the table of contents. If the CDRH Premarket Review Submission Cover Sheet is used, the statement should attached as a separate page. Truthful and Accurate Statement
Prepare a labeling section to include copies of all proposed labels, labeling, package inserts, service manuals, instructions for use, advertising and/or promotional materials. The directions for use should include a specific intended use statement and any warnings, contraindications, or limitations. The material does not have to be glossy, finished labeling or promotional material, draft is sufficient. However, the labeling you submit should be final draft. Copies of labeling for the predicate device(s) is recommended. Labeling guidance is provided below:
This section should include both a narrative description of the device and a physical or technical description.
The narrative description of the "new" device should include the indications for use, principles of operation, power source, composition and other information necessary to understand the device. If the 510(k) is for an accessory or component sold to an end-user, describe a typical device with which the accessory or component will be used. List all variations of the "new" device which you intend to market.
The physical description of the "new" device may include labeled diagrams, photographs or pictures, engineering drawings, schematics, etc. These may include all internal and external, assembled and unassembled, interchangeable, etc., parts of the device and should address their name and function. In addition, the description should include the length, width, height, diameter, weight, etc., of the device and identify any parts which are intended for single use.
Device specific guidance documents, if available, usually provide extensive information on the level of detail which should be included in the specifications list.
The device specifications are the basis for the comparison of features between the new and the legally marketed device to which compared (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. You should include a comparison table AND discussion of the similarities and differences of your device compared to one or more predicate devices to which you are claiming equivalency.
The equivalence information should be provided in a clear and comprehensive format. A chart, table or other side-by-side comparision is a systematic way to compare the devices. Side-by-side comparisions, wherever possible, are desirable. For some devices a simple table of comparision which lists characteristics will be sufficient to establish equivalence. Often, information is necessary to resolve questions of safety or effectiveness, especially where differences in technologies exists between the predicate and the new device. It must be shown that technological differences do not adversely affect safety and effectiveness. Supporting information can be obtained from bench testing, animal studies or clinical studies (information gathered from medical literature) or clinical trials.
State whether the legally marketed device for comparision is a preamendments device, or a device which has been granted marketing clearance by FDA following the submission of a 510(k). Provide the 510(k) document control number (i.e., K followed by 6 digits) for the device to which you are claiming equivalency, if known.
The comparison table should identify relevant similarities and differences in areas such as:
•indications for use
•where used (hospital, home, ambulance, etc)
•energy used and/or delivered
•compatibility with the environment and other devices
The discussion of the similarities and differences should elaborate on the similarities identified in the table of comparisons and justify the differences with supporting rationale and/or data. It is recommended to submit labeling for the device to which you are claiming equivalency.
Most 510(k)s will include some type of performance data. The extent of performance data will depend on the complexity of the device and its intended use and indications. Performance data should be provided to help demonstrate SE of your device to one or more legally marketed devices (predicate device). The data may include test results from engineering, bench, design verification, human factors, and animal testing, and clinical studies and clinical trials. Tests should be conducted on all sizes and models of the device in a manner as similar as possible to how the device will be used. The results of testing and methodology / parameters used for testing should be included. Information on the extent of performance testing as well as the extent of specification documentation can be found in the product specific guidance documents, if one has been prepared for your device by FDA. Search the Guidance Document page to determine if guidance documents are available for your type of device. For more information regarding the content and format of bench testing information, please see FDA's guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions." For more information on when FDA may request clinical performance data to support a substantial equivalence determination, please refer to Section F of the guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)].
Additional information may be required under certain conditions, such as if your device contains software or a color additive, is labeled sterile, or emits electronic radiation. See "Special Considerations" under Device Advice Premarket Notification 510(k) for additional guidance.