Guidance for FDA 510 (k) Premarket Approval



For Medical Devices in the U.S Market


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What is a 510(k)?



FDA Premarket Notification



A 510 (k) is the technical documentation required for those intending to market a medical device in the US. 510(k)’s are usually for Class II medical devices (although also some Class I, and Class III medical devices). A 510 (k) premarket submission demonstrates a medical devices safety and effectiveness for use.


In the submission you will need to detail the similarities and differences of your medical device with a similar device that already exists on the market.



What needs to be included in a 510(k)?



According to the FDA, the contents of your 510(k) submission should be presented in “an organised, tabulated document” and should contain:

  • Logical presentation of the data
  • Scientific soundness of the test and data analysis
  • Relevance of the test programme to the device and intended use
  • Completeness of the summary report of the test or studies

FDA 510(k) Useful Information & FAQ's

How Cranage Veritas can help with your Medical Device FDA 510(k)



We understand how important your medical device is to you, and to those it helps, which is why getting your product to market as efficiently as possible is our goal. Our experts have all the knowledge, skills and experience to help make your medical device 510(k) submission as clear and efficient as possible, to reduce the potential for revisions, reducing the total time taken and costs involved.


We have experience assisting clients in:

  • Classification of your medical device or equipment
  • Identifying a predicate device
  • Identifying the relevant testing procedures required for your medical device or equipment
  • Assistance in compiling your technical documentation
  • Technical documentation review

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Cranage Veritas



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Cranage Veritas Limited
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Shannon
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Ireland
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