FDA 510(K) Submission

FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). 510(k) Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." 

FDA 510(k) submissions for medical devices are reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter. FDA 510(k) is not FDA approval or FDA certification of the medical device, it is only a marketing clearance. FDA does not provide approval or certification through 510 k process nor issue a certificate of registration, but you will get a 510 k number.

Please note that FDA does not perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after FDA 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (QSR) inspection at any time after FDA 510(k) clearance.

FDA does not specify who must apply for a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require FDA 510(k) submission.

The following four categories of parties must submit FDA 510(k) :

  1. Domestic manufacturers introducing a device to the U.S.market;

    Finished device manufacturers must submit FDA 510(k) if they manufacture a device according to their own specifications and market it in the U.S. Accessories to finished devices that are sold to the end user are also considered finished devices. However, manufacturers of device components are not required to submit a 510(k) unless such components are promoted for sale to an end user as replacement parts. Contract manufacturers, those firms that manufacture devices under contract according to someone else's specifications, are not required to submit FDA 510(k).

  2. Specification developers introducing a device to the U.S. market;

    A specification developer develops the specifications for a finished device, but has the device manufactured under contract by another firm or entity. The specification developer submits the FDA 510(k) Notification, not the contract manufacturer.

  3. Repackers or relabelers who make labeling changes or whose operations significantly affect the device.

    Repackagers or relabelers may require FDA 510(k) Submission if they significantly change the labeling or otherwise affect any condition of the device. Significant labeling changes may include modification of manuals, such as adding a new intended use, deleting or adding warnings, contraindications, etc. Operations, such as sterilization, could alter the condition of the device. However, most repackagers or relabelers are not required to submit a 510(k).

  4. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market also require FDA 510 (k) submission

Please note that all manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to follow design controls during the development of their device. The holder of a 510(k) must have design control documentation available for FDA review during a site inspection. In addition, any changes to the device specifications or manufacturing processes must be made in accordance with the Quality System regulation (QSR) and may be subject to a new 510(k). 

Liberty Management Group can assist you to get FDA 510(K) Clearance (Approval) for your medical device; our experienced consultants can provide you the right guidance in FDA 510 k submission requirements. Our consultant can help you from predicate device selection through establishment registration and listing. LMG provides US Agent service for foreign medical device manufacturers. 

Our services includes:

  • Identification of device class, product code and regulation number
  • Identification of predicate device
  • Identification of test standards
  • Identification of 510k test requirements
  • Identification testing or certification lab
  • medical device label review
  • Preparation of 510k documents
  • Submission of 510k documents to FDA
  • Provide US Agent service for 510 k
  • Communicate to FDA on behalf of our client
  • Prepare clarifications to questions from FDA
  • Assistance in transfer of 510k review fees to FDA
  • Notify the new 510 k number
  • Assistance in Establishment registration with FDA
  • Assistance in Device Listing with FDA

Sections included in FDA 510(K) submission, Please note there is no 510(k) form.

  1. FDA Medical Device User Fee Cover Sheet

  2. FDA Premarket Review Submission Cover Sheet

  3. FDA 510(k) Cover Letter

  4. FDA 510(k) Indications for Use Statement

  5. FDA 510(k) Summary or FDA 510(k) Statement

  6. FDA Truthful and Accuracy Statement

  7. FDA Class III Summary and Certification

  8. Financial Certification or Disclosure Statement

  9. Declarations of FDA Conformity and Summary Reports

  10. FDA 510 (k) Executive Summary

  11. Medical Device Description

  12. FDA 510(k) 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

510k approval process flow diagram

FDA Registration - Latex and Nitrile gloves

Tests required for latex and nitrile gloves - FDA Submission

Biocompatibility tests required for examination and surgical gloves



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