510k submissions

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One of the first steps toward selling a Class II medical device or IVD in the United States is to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission. The FDA does not “approve” medical devices or IVDs for sale under the 510(k) process; the agency gives “clearance” for them to be sold in the U.S. The terms “FDA approval” and “FDA clearance” are used interchangeably.

Manufacturers wishing to introduce Class II medical devices (and a small number of Class I and III devices) or IVDs to the US market must submit a 510(k) to the FDA. A 510(k) premarket notification is also required for manufacturers changing the intended use of their medical device, or changing the technology of a cleared device in such a way that it may significantly affect the device’s safety or effectiveness.

So that the submission process is effective and less likely to be rejected for clearance by the FDA. We find that a two-step approach is the most effective and leads to less chance of a rejection for clearance by the FDA.

Step 1 –

  • The proposed intended use and design of your device help us determine the proper FDA product code and regulation number, which may point to device-specific guidance documents or required standards.
  • We evaluate similar devices that already have FDA 510(k) clearance to determine whether any are suitable for use to determine substantial equivalence for your device. These are referred to as predicate devices.
  • We provide a product-specific list of documents and information needed for the 510(k) submission.
  • An assigned U.S. regulatory consultant will review the information to determine its suitability for the 510(k) submission.
  • After evaluating this documentation, we prepare a detailed gap analysis report identifying incomplete or missing information required for a complete 510(k) submission.

Once you receive the gap assessment, Patient Guard can help you close these “gaps” to ensure you have the best chance at a successful submission.

Step 2 –

When all required documents and information have been received, Patient Guard will prepare your final 510(k) submission. This will consist of the following:

  • Prepare a technical comparison of your medical device to the predicate device(s).
  • Prepare all 21 sections of the FDA 510(k) application.
  • Submit the hard copy and eCopy of the 510(k) to the CDRH division within the FDA and be the correspondent for further communications with the FDA.
  • Coordinate payment of FDA 510(k) submission fees on your behalf.
  • Immediately communicate with you regarding all information received from the FDA following the 510(k) submission, and assist in addressing their requests for additional information, if applicable.

Once clearance has been granted by the FDA, they will issue a clearance letter, the FDA do not issue certificates like a notified body would in the EU.

Once clearance is granted by the FDA the 510(k) remains valid for as long as no changes are made to the medical device, if changes are made to the medical device, then another 510(k) would need to be submitted. This is different than in the EU where a notified body would review the technical file once the CE mark certificate is due for renewal.

Devices that share the same FDA classification regulation/product code can often be “bundled” into a single submission. There are also times that devices with different product codes may be submitted in a single 510(k), if they are intended to be used together to perform the intended use of the ‘family.’

For foreign manufacturers home country approval is not required to receive FDA clearance.

What are the costs involved?

The cost of submission by the FDA is updated each year, there is the standard fee or if you are a small business you can apply for the small business fee. As well as the 510(k) submission fees you will need to also pay an annual FDA registration fee.

Details of the fees for this year can be found here: Medical Device User Fee Amendments (MDUFA)

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