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What is the special 510(k) program?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

A Special 510(k) is used for existing devices that have well-established methods to evaluate changes to one technical discipline. A special 510(k) should be submitted when:

  • The proposed change is submitted by a manufacturer legally authorized to market the existing device
  • Performance data is unnecessary
  • All data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format

Some questions to consider in the development of your special 510(k) submission include:

  • Is it a change to the manufacturer’s own device?
    The special 510(k) should be for a change to the submitter’s own legally marketed predicated device. It relies on the previous review of detailed information, and a manufacturer who modifies its own device is able to conduct the risk analysis necessary to demonstrate that design output meets design input.
  • Are performance data needed to evaluate the change?
    Manufacturers should use their design control procedures and consider the information necessary to support substantial equivalence to determine whether performance data is needed. Verification and validation testing may not be necessary to support SE.
  • Is there a well-established method to evaluate the change?
    Well-established methods should be available to evaluate the change under design controls. These methods may include:
    Submitter’s methods, protocols, and acceptance criteria to support previously cleared 510(k)
    FDA-recognized voluntary consensus standard or FDA guidance document
    Qualified medical device development tools (MDDTs)
    Widely available and accepted methods in the public domain or found acceptable by FDA through the submitter’s won 510(k) clearance, a granted De Novo classification request, or a PMA approval
  • Can the data be reviewed in a summary or risk analysis format?
    The results from verification and validation associated with design or labeling changes should be able to be placed in a summary or risk analysis format without losing information necessary to support substantial equivalence. If it cannot, the FDA will consider converting to a Traditional 510(k).

The average review time for this submission is 30 days.

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