US FDA 510k Consultants

Market any Kind of Medical Device in US under any class of device intended for human use for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act. There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order "clears" the device for commercial distribution.    

A 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 means it is substantially equivalent to a legally marketed device and that is not subject to PMA. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate."  Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. 

Until the submitter receives an order declaring a device substantially equivalents, the submitter may not proceed to market the device. Once the device is determined to be substantially equivalents it can then be marketed in the U.S. The substantially equivalent determination is usually made within 90 days and is made based on the information submitted by the submitter.

Please note that FDA does not perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance.

The 510 k is required for

  • Domestic manufacturers introducing a device to the U.S. market.
  • Repackers or relabelers who make labeling changes or whose operations significantly affect the device.
  • Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market. 
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A Manufacturer needs 510k when:

  • Anyone who wants to sell a device in the U.S. is required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date. 
  • Change in the intended use for a device which you already have in commercial distribution.
  • If there is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness. 
  • A new 510(k) submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different indication for use.

Our experienced consultants guide you in the right direction about requirements and submission process to get the K Number for your medical device. Our assured service is fast and guaranteed. Phase by phase payments..

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When a 510(k) is not required

Frequently asked Questions

21 CFR 820 – Medical Device GMP Requirements

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