Here's an interesting breakdown of the 510K process...
There are three types of FDA 510(k) Premarket Notifications. The most common is the Traditional 510(k) which is required for most new products. Many people confuse the 1-2 page “Summary” published on the FDA website with the complete application that must be submitted to the FDA. This summary is exactly what it means - a summary. A final 510(k) application when submitted is often 50-100 pages in length, not including any applicable testing reports for your product. The FDA does not publish a template that you must follow for a 510k submission, but it must address the 21 sections shown below.
1.Medical Device User Fee Cover Sheet
2.CDRH Premarket Review Submission Cover Sheet
3.510 (k) Cover Letter
4.Indications for Use Statement
5.510 (k) Summary or Statement
6.Truthful and Accuracy Statement
7.Class III Summary and Certification
8.Financial Certification or Disclosure Statement
9.Declarations of Conformity and Summary Reports
10.Executive Summary
11.Device Description
12.Substantial Equivalence Discussion
13.Proposed Labeling
14.Sterilization and Shelf Life
15.Biocompatibility
16.Software, if applicable
17.Electromagnetic Compatibility and Electrical Safety, if applicable
18.Performance Testing – Bench, if applicable
19.Performance Testing – Animal, if applicable
20.Performance Testing – Clinical, if applicable
21.Other
Here is some additional information on those sections as provided by the FDA.
1. Medical Device User Fee Cover Sheet
The Medical Device User Fee Cover Sheet and receipt of the user fee payment, allow FDA to begin processing your submission; therefore, you should provide a Medical Device User Fee Cover Sheet with your 510(k) submission, unless it is a third-party review submission. Third-party review submissions are exempt from user fees. Although the following 510(k) submissions are also exempt from user fees, we recommend you include a Medical Device User Fee Cover Sheet, and use it to indicate the type of exemption that applies in the case of 510(k) submissions: intended solely for pediatric use (a change in the intended use from pediatric use to adult use requires the submission of a new 510(k) in accordance with 21 CFR 807.81(a)(3); and an associated fee) submitted by a state or Federal government entity (exempt from the FDA user fee unless the device is to be distributed commercially).
2. CDRH Premarket Review Submission Cover Sheet
The CDRH Premarket Review Submission Cover Sheet is a voluntary form used to help provide basic administrative information for all types of premarket notification submissions.
3. 510(k) Cover Letter
We recommend that you include a 510(k) Cover Letter with your submission. See Appendix A for more information on the proposed and suggested content of the 510(k) Cover Letter. Appendix A describes key information that may be useful to FDA in the initial processing and review of the 510(k) submission. In contrast with the CDRH Premarket Review Submission Cover Sheet from Section 2, the 510(k) Cover Letter described in Section 3 is intended to be more descriptive of a 510(k) submission.
4. Indications for Use Statement
We recommend that you use this section to provide the indications for use statement, which is a document where you identify and describe the specific indications for use statement for the device(s) included in the 510(k) submission. Your indications for use statement should be exactly the same as the indications for use listed throughout the rest of your 510(k) submission, including the indications for use in the device labeling. We believe that in order for FDA to adequately review your submission you should identify whether the device is intended for prescription use and/or over-the-counter use.
5. 510(k) Summary or 510(k) Statement
In accordance with 21 CFR 807.87(h), each 510(k) submission must include either a 510(k) Summary (21 CFR 807.92) or 510(k) Statement (21 CFR 807.93). We recommend that you use Section 5 to provide the 510(k) Summary or 510(k) Statement. A 510(k) Summary provides a brief summary of the device included in the 510(k) and the supporting information. A 510(k) Statement is a certification that the 510(k) holder will provide a copy of the 510(k) submission, with certain exclusions, to any person within 30 days of a written request.
6. Truthful and Accuracy Statement
In accordance with 21 CFR 807.87(k), all 510(k)s 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 submitter should sign and date the statement.
7. Class III Summary and Certification
If your 510(k) is for a device type classified into class III for which we have not called for PMAs, it must contain a Class III Summary and Certification in accordance with 21 CFR 807.87(j) and 807.94. The Class III Summary and Certification provide a review of the risks and adverse events known and associated with the general category of devices into which the proposed device falls.
8. Financial Certification or Disclosure Statement
In accordance with 21 CFR 807.87(i), if you submit information from clinical studies, you must submit a financial certification and/or a disclosure statement for each clinical investigator who participated in your study.
9. Declarations of Conformity and Summary Reports
If your 510(k) is an Abbreviated 510(k) submission, we recommend that you use this section to provide the information regarding any declarations of conformity to a standard or a summary report recommended in any relevant device-specific guidance. As mentioned in the definitions section of this guidance, an Abbreviated 510(k) is a type of 510(k) in which you choose to declare conformance to a recognized standard for any part of the device design or testing or you choose to prepare a summary report to a guidance. If you choose to rely on a recognized standard or a guidance for any part of the device design or testing, you may include either a: declaration of conformity to the standard or summary report recommended in any relevant device-specific guidance; or a statement that testing will be conducted and meet specified acceptance criteria before the device is marketed. Because a declaration of conformity is based on results from testing, we believe you cannot properly submit a declaration of conformity until you have completed the testing the standard describes.
10. Executive Summary
In this section of your 510(k), we recommend that you provide an executive summary of the 510(k), which should include a: concise description of the device, including the indications for use and technology; device comparison table; and concise summary for any performance testing in the submission. The description, although concise, should be sufficient to provide an overall understanding of the device. The device comparison table should outline the differences and similarities between your device and the predicate. We recommend that you also provide a discussion of how this comparison supports substantial equivalence. The summary for each performance testing section (i.e., sections 18, 19, and 20) should be sufficient to provide a broad understanding of the type of testing performed, the methods used, and your conclusion from the results.
11. Device Description
We recommend that you describe the performance specifications and include a brief description of the device design requirements in this section. We also recommend that you identify all models, as well as all accessories or components, included in the submission. If diagrams, dimensions, tolerances, and/or schematics are useful to fully describe and characterize the device, we recommend that you include them for each device, accessory or component included in the 510(k) submission. We also recommend that you provide a list of all patient contacting components and their respective materials.
12. Substantial Equivalence Discussion
In the substantial equivalence section, we recommend that you identify the predicate and identify its trade name, model number, 510(k) submitter/holder, and 510(k) number, if available. You may choose to identify, compare, and test against more than one predicate, if, for example, your device has two features or indications not previously combined in a single predicate. We recommend that you provide a detailed comparison between your device and the predicate sufficient to demonstrate the substantial equivalence of the devices, as applicable, in terms of: indications for use; technology; and performance specifications, including any testing.
13. Proposed Labeling
The 510(k) must include proposed labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e). If the device is an in vitro diagnostic device, the labeling should additionally satisfy the requirements of 21 CFR 809.10. Generally, the term “labeling” includes the device label, instructions for use, and any patient labeling.
14. Sterilization and Shelf Life
For devices sold as sterile, we recommend that you follow the guidance, Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA. For devices that are reprocessed single use devices, please refer to Guidance for Industry and FDA Staff – Medical Device User Fee and Modernization Act of 2002 Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices. For a submission that identifies a shelf life for the device, your shelf life should be supported by appropriate bench tests and/or sterilization (packaging) validation.
15. Biocompatibility
If your device contains components that come into direct or indirect contact with patients, you should evaluate the biocompatibility of the patient-contacting materials. You should select biocompatibility tests for the duration and type of contact appropriate to your device design and submit the pass/fail criteria or in some cases, a summary of the results. If identical materials are used in a predicate with the same type and duration of patient contact, you may identify the predicate in lieu of performing biocompatibility testing and state that your device is comprised of identical materials and that are processed by identical manufacturing methods. This is most appropriate if you are the manufacturer of the predicate and you have complete documentation with respect to the manufacturing methods and materials employed.
16. Software
This section should include the appropriate software documentation as described in the guidance titled Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. As discussed in the guidance, we recommend that you identify the “level of concern,” (minor, moderate, or major) associated with your device and provide documentation consistent with that level.
17. Electromagnetic Compatibility and Electrical Safety
If your device design includes an electronic component , we recommend that you evaluate its electromagnetic compatibility (EMC). EMC encompasses both emissions (interference with electronic products) and immunity (interference with device performance created by emissions from other electronic products). We recommend you test your device according to IEC 60601-1- 2 Medical Electrical Equipment — Part 1: General Requirements for Safety; Electromagnetic Compatibility — Requirements and Tests (Second Edition, 2001) or equivalent method to demonstrate the EMC characteristics of your device. If your device design results in patient contact with any electrically powered component, FDA recommends that you follow IEC 60601 1 (1988): Medical electrical equipment – Part 1: General requirements for safety, including Amendment 1 (1991) and Amendment 2 (1995) or an equivalent method.
18. Performance Testing – Bench
If you submit bench test results to support substantial equivalence, we recommend you include the following information in this section. If the device is an in vitro diagnostic device, refer to Appendix B. You should describe the bench testing and provide the results that support the performance characteristics of your device. Generally, all submissions should include the information below; however, if a relevant device-specific guidance is available, you should follow the recommendations in that guidance document. We also recommend that your conclusions describe any comparison testing with the predicate in terms of substantial equivalence.
19. Performance Testing – Animal
If you submit animal test results to support substantial equivalence, we recommend you include the following information in this section. If the device is an in vitro diagnostic device, refer to Appendix B. If you conducted animal testing, we recommend that you describe the tests and provide the results that support the performance characteristics of your device. 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. The branch or team responsible for the review of your device is also available to assist you with any questions about animal testing. We also recommend that your conclusions describe any comparison testing with the predicate device in terms of substantial equivalence.
20. Performance Testing – Clinical
If you submit results from clinical studies to demonstrate substantial equivalence, we recommend you include the following information in this section. If the device is an in vitro diagnostic device, refer to Appendix B. FDA will always consider alternatives to clinical studies when the proposed alternatives are supported by an adequate scientific rationale. Our recommendations for clinical testing typically depend on many factors including device type, intended use, design, safety profile, and clinical experience. Generally, all submissions that describe clinical studies should include the information (required by FDA); however, if a relevant device-specific guidance is available, you should follow the recommendations in that guidance document. The branch or team responsible for the review of your device is also available to assist you with any questions about studies. If your submission describes clinical studies, we recommend that you provide the clinical protocol. We also recommend that your conclusions discuss any comparison testing with the predicate device in terms of substantial equivalence.
If your study is considered significant risk, the study must be conducted under the IDE regulation, 21 CFR Part 812 if it is conducted in the United States. If, however, your study is considered non-significant risk, the study is subject to the abbreviated requirements of 21 CFR Part 812.2(b) only. In all cases, sponsors of clinical trials must comply with the regulations governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).
From what it sounds like, we are at the end of the process and still arond the 150 day window!
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