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Does your software device qualify for the abbreviated 510(k) program?

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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.

An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 807.87. In an Abbreviated 510(k), FDA may consider the contents of the documentation to be appropriate supporting data within the meaning of 21 CFR 807.87(f) or (g).

If you choose to rely on an FDA-recognized standard for any part of the device design or testing, you may include either a:

  • statement that testing will be conducted and meet specified acceptance criteria before the product is marketed
  • declaration of conformity to the standard

Because a declaration of conformity is based on results from testing, you cannot properly submit a declaration of conformity until you have completed the testing the standard describes. For more information, please refer to section 514(c)(1)(B) of the Act and the FDA guidance, “Use of Standards in Substantial Equivalence Determinations.”

If you declare conformance to a standard that recommends specific tests or testing methods for your Software Device, you should submit documentation of pass/fail criteria and associated test results along with your declaration of conformance. FDA also recommends that you list deviations from the tests and test methods specified in the standard and explain these deviations in terms of the impact on the safety and effectiveness of the Software Device. A list of FDA recognized consensus standards is available on the CDRH web site.

 

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