510(k) Submissions: 21 Elements You Need to Know

• By: Staff Editor
• Date: March 15, 2016
• Source: ComplianceOnline

Does your medical device require a 510(k) application? The process of submitting a 510(k) application can pose many challenges for device manufacturers as each 510(k) submission is dynamic depending on the type of device, the risk level, its history, etc. A final 510(k) submission should be a completed comprehensive document including all 21 sections and other information needed for approval by the FDA. Therefore, it is vital to have a strong understanding of the latest 510(k) submission requirements and how they relate to your device.

What Type of 510(k) is Required for Your Device?

There are three types of 510(k) that may be submitted to FDA. The manufacturer should carefully assess the changes made to their device in terms of design control process, intended use, labeling, packaging, shelf life etc. to decide the type of 510(k) necessary for their product. The types of 510(k) are:

A Traditional 510(k) can be filed for an original 510(k) or when modifications are made to a previously cleared device.

An Abbreviated 510(k) is submitted when guidance documents exist, a special control has been established and a standard has been identified. Sections within an Abbreviated 510(k) are same as Traditional 510(k) but with the benefit of ‘Expedited Review’.

A Special 510(k) submission is aimed for review and clearance of a modification (intended use or fundamental scientific technology) to a manufacturer’s device which has been already cleared for commercial distribution.

21 Elements Essential for 510(k) Submissions

Here is the list of basic 21 elements that need to be addressed in the traditional 510(k) submissions:

1. Medical Device User Fee Cover Sheet (Form FDA 3601): It allows the FDA to begin processing application submission. After completing the cover sheet, a unique payment identification number is assigned that tracks your fee payment and submission.
2. CDRH Premarket Review Submission Cover Sheet (Form 3514): This is a voluntary form to provide basic administrative information including type of submission, contact information, reason for submission, product information, applicable standards etc.
3. 510 (k) Cover Letter: Cover Letter is the most descriptive section of the submission. It should include the administrative information (if Premarket Review Submission Cover Sheet is not included), basis for the submission (new device; modification of a legally marketed device; new indication for use), and design and use of the device.
4. Indications for Use Statement: Information written on this statement is uniform and identical in words throughout the application in the labeling, advertising, instructions for use, service statement and other sections also.
5. 510(k) Summary or 510(k) Statement: 510(k) Summary or 510(k) Statement, which one you use is entirely up to you – there are pros and cons for both. 510(k) summary covers the key issues of the submission, device description comprising name, classification and code, substantial equivalent rationale, safety and effectiveness of the device. 510(k) Statement is a certification that the 510(k) holder will provide a copy of the 510(k), with exclusions, to any person within 30 days of written request.
6. Truthful and Accuracy Statement: It certifies that all information in the 510(k) is true and that nothing has been omitted.
7. Class III Summary and Certification: If you have a Class III device, you are required to provide a Class III Summary and Certification- a review of risks and adverse events associated with the device category into which the device falls.
8. Financial Certification or Disclosure Statement (Form FDA 3454): This is only needed if clinical data is submitted in the 510(k).
9. Declarations of Conformity and Summary Reports: This section is to be used with Abbreviated 510(k). It provides information regarding any declarations of conformity to a standard or summary report that you are going to use.
10. Executive Summary: This is actually the part of the 510(k) where you are going to start writing things. It includes description of the device, indications for use, device comparison table / matrix, to predicate(s) and summary of performance testing.
11. Device Description: What are performance specifications of your device? What were your device design requirements? Also covers the failure mode analysis, differences from the predicate and how they don't affect safety or if they do, how will you address that? And list of all patient contacting components and their respective materials.
12. Substantial Equivalence (SE) Discussion: This section is going to provide the detailed comparison between your device and predicate device including indications for use, technology, and performance specifications.
13. Proposed Labelling: All inner labelling, all outer labelling, any instructions for use, package insert etc. should be included.
14. Sterilization and Shelf Life: Sterilization type, contractor, residuals if applicable, accelerated aging studies, functional testing etc.
15. Biocompatibility: This is only required if the device comes into direct or indirect contact with the patients and the data varies according to the type of contact and length of the regression of contact.
16. Software (if applicable): If your device uses software, you need to include the software documentation and comply with the requirements of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
17. Electromagnetic Compatibility and Electrical Safety: This is for devices that comprise electronic components. You need to include about applicable standards such as IEC 60601-1-2, IEC 60601-1 etc.
18. Performance Testing – Bench: Includes list of tests conducted, test protocol and objective, describe test articles, parameter(s) measured, acceptance criteria, summary of results and conclusion.
19. Performance Testing – Animal: Same information as the bench performance testing and cadaver studies are included as well.
20. Performance Testing – Clinical: Same information as the bench. Additionally, include a certification that all applicable clinical trial information has been submitted to the ClinicalTrials.gov data bank.
21. Others: Generally include additional information on hazard analysis, risk management, failure modes and effects analysis, MAUDE, adverse events / MDR databases analysis etc.

Want to learn more about medical device regulatory compliance processes and practices, 510(k) submissions requirements and contents. Check out the following links:

http://www.complianceonline.com/medical-device-510-k-applications-made-simple-webinar-training-701082-prdw

http://www.complianceonline.com/medical-device-510-k-submission-requirements-webinar-training-701016-prdw