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How do 510(k) submissions review measures taken towards patient safety?
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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.

Ensuring patient safety is reviewed in three different categories:

  • Proposed Labeling: Includes device label, instructions for use, package insert, and patient labeling. See 21 CFR 807.87 and 21 CFR 809.10 for more information.
  • Sterilization/Shelf Life: If the device is non-sterile, state that very clearly. Prove that the device is sterile at the end of the shelf life and that the device performs as expected. This may not always be applicable to the proposed device.
  • Biocompatibility: Important for devices that has direct or indirect patient contact. The only exception is if the proposed device is identical (in both material and manufacturing) to the predicate device. See ISO 10993-1 for guidance.

These sections may not be entirely applicable to the proposed device, but it is important to include them regardless.

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