FDA 510(k) Submission
About 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) :
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).
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.
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).
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).Â
Liberty Management Group can assist you to get FDA 510(K) Clearance 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.Â
FDA 510(k) Consulting Services
Predicate Device Selection
Identification of appropriate predicate devices based on classification and intended use.
510(k) Submission Preparation
Complete preparation of the 510(k) package including all required sections.
Test Requirements Guidance
Guidance on biocompatibility, performance testing, and standards.
FDA Interaction and Review Meeting
Assistance with Q-submissions, additional information requests, and scheduling a meeting with the FDA review team.
Post-Clearance Registration
Assistance with Establishment registration, medical device user fee payment, and device listing following 510(k) clearance.
Medical Device US FDA Agent Service
US Agent service for foreign medical device manufacturers 510(k) submission and establishemnet registration.
A Proven Track Record of FDA 510(k) Clearances
Our history of success is public record. Click any number to verify directly on the official FDA 510(k) database.
Frequently Asked Questions
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