The FDA 510k Submission Process

The 510k submission process can be overwhelming to most manufacturers. Device Registration and 510k Submissions are typically the domain of Regulatory Departments of large companies, or professional specialists in that field. FDA Specialists are usually attorneys or consultants like Denterprise International, Inc.

510k Submission Methods:

Traditional 510(k)

The Traditional 510(k) may be used for any original 510(k) or for a modification to a previously cleared device under 510(k). The traditional method is the original complete submission as provided in 21 CFR 807. The Traditional 510(k) method may be used under any circumstances.

Most companies must submit a Traditional 510k Premarket Notification. Below are the sections required:

1. Medical Device User Fee Cover Sheet
2. CDRH Premarket Review Submission Cover Sheet
3. 510k Cover Letter
4. Indications for Use Statement
5. 510k Summary
6. Truthful and Accuracy Statement
7. 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
17. Electromagnetic Compatibility and Electrical Safety
18. Performance Testing – Bench
19. Performance Testing – Animal
20. Performance Testing - Clinical
21. Other

Special 510(k)

The Special 510(k) is used for device modifications and utilizes the design controls aspect of the Quality System (QS) regulation (21 CFR 820.30). Special 510(k)s may be submitted for a modification to a device that has been cleared under the 510(k) process. If a new 510(k) is needed for the modification and if the modification does not affect the intended use of the device or alter the fundamental scientific technology of the device, then summary information that results from the design control process can serve as the basis for clearing the application. Under the Quality System regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to section 820.30 Design Controls. The Special 510(k) allows the manufacturer to declare conformance to design controls without providing the data. Manufacturers of Class I devices requiring 510(k) may elect to comply with the design control provision of the QS regulation and submit a Special 510(k). Under the Special 510(k) option, 510(k) holders who intend to modify their own legally marketed device will conduct the risk analysis and the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements. Once the 510(k) holder has ensured the satisfactory completion of this process, a "Special 510(k): Device Modification" may be submitted. While the basic content requirements of the 510(k) (21 CFR 807.87) will remain the same, this type of submission should also reference the cleared 510(k) number and contain a "Declaration of Conformity" with design control requirements. In order to provide an incentive for 510(k) holders to choose this option for obtaining FDA clearance for device modifications, the Office of Device Evaluation (ODE) and Office of In
Vitro Diagnostic Device Evaluation and Safety (OIVD) intend to process Special 510(k)s within 30 days of receipt by FDAs Document Mail Center (DMC). Some device modifications may be implemented without submission of a new 510(k). The
submitter should review Is a new 510(k) required for a modification to the device? to assure that a new 510(k) is required for the modification to the device. Abbreviated 510(k) Device manufacturers may choose to submit an Abbreviated 510(k) when:

• a guidance documents exists,
• a special control has been established, or
• FDA has recognized a relevant consensus standard.

An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 807.87 [Traditional 510(k)]. However, in an Abbreviated 510(k) submission, firms elect to provide summary reports on the use of guidance documents and/or special controls or declarations of conformity to FDA recognized standards to expedite the review of a submission.

The Approval Process:

Assuming you have determined that your medical device does need a 510k, here is how the process works:

1- Compile the information needed and prepare the submission.

The specific information that will be required in the application includes, but is not limited to:

• statement of intended use for the device
• description of how it operates
• technical drawings, diagrams and photographs of the device
• technical characteristics of your device compared to others already approved
• proposed labeling, marketing materials and Instructions (User Manual)
• the difference in your product compared to the ‘predicate’ devices already approved by the FDA and how this may affect safety
• testing data, including clinical data if applicable
• maintenance and troubleshooting procedures, if applicable
• compliance with any published Standards or Guidelines, if applicable

2 – The FDA reviews your 510k application

The FDA legally has 90 days to review your submission. During that process they may ask you for additional information at which time the ‘clock’ is stopped and then resumes upon the FDA’s receipt of your answers to their questions.

If approved, they will mail you a letter, with your assigned 510k number, that says the ‘have determined that your device is substantially equivalent to legally marketed predicate devices …and you may therefore market the device subject to general controls provisions of the Food, Drug and Cosmetic Act’. This is not an Approval. They are saying that your device is much the same as other devices (predicates) already approved by the FDA. You will not receive a certificate from the FDA, but this letter will be available on the FDA database as proof to your customers that your product is approved for sale in the US.

3 – Register your company and device with the FDA

Once you have received your FDA 510k ‘clearance’ letter, the final step is to complete the FDA device listing and establishment registration using the FURLS system on the FDA website. You are then open to random inspections for compliance with Good Manufacturing Practices. There are also certain fees that must be paid.