FDA 510-K Submission Process

Type of 510k and Submission Methods

 

Traditional 510k:  Most companies introducing a new Class II device must submit a Traditional 510k Premarket Notification.  This is a full submission with 21 sections. FDA’s clearance of a Traditional 510k is 90 days.

 

 Special 510k:  This clearance is used when there is a design change or a modification to a device you have previously cleared that does not affect the intended use.  FDA’s clearance of a Special 510k is 30 days.

 

Abbreviated 510k:  There are specific guidelines for this 510k clearance.  There has to be guidance documents from FDA for the specific medical device that is to be cleared.  A special control has been established by FDA for this device and consensus standards.  FDA’s clearance of an Abbreviated 510k is 90 days.

 

Our job is to provide the required information about your new device that we match up to a device that has already been cleared by FDA.  The device that we match your device to is called a predicate device.  We have to prove to FDA the substantial equivalence of your device to the one they cleared.

Without us. . .

You will have to determine which 510k is correct for your device with FDA.

 

What is Substantial Equivalence?

This is the method to prove to FDA that your new device is at least as safe and effective as the predicate device.

A device is substantially equivalent if, in comparison to a predicate it:

  • has the same intended use as the predicate; and
  • has the same technological characteristics as the predicate; 
    or
  • has the same intended use as the predicate; and
  • has different technological characteristics and the information submitted to FDA;
    • does not raise new questions of safety and effectiveness; and
    • demonstrates that the device is at least as safe and effective as the legally marketed device.

This does not mean that the devices must be identical.  We establish the equivalence with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.

 

Without us. . .

You will have to determine the best method to prove substantial equivalence of your device to FDA.

 

Here at 510k FDA Consulting  we will guide you through this process to gather all of the above data that applies to your device.  We have a list of the documents that are needed for your specific device.  We review the predicate together and then set a plan in motion for your new device.  We receive your information through email and then we write and prepare the 21 sections of the 510k submission.

 

The world is a changing place with technology.  It is our job to keep up with the changes that FDA makes to the 510k process.  As our client, we want to commend you for your interest to the development of new devices that improves lives and convenience for the patients that use or need them.  We are pleased to have the opportunity to work with you and for you to clear your device for the U.S. marketplace.  We look forward to you joining our team to achieve the FDA clearance for your new medical device.

Contact:  joyce@510kFDA.com

 

 

 

 

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.

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.

510K FDA 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