FREQUENTLY Asked Questions

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

View All FAQs
About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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.

Related Terms:
Related FAQs:
More Questions? We're here to help!
SPEAK WITH A SPECIALIST