Guidance on 510(k) marked as sterile

On January 21, 2016, FDA-CDRH issued a guidance document, updated March 16, 2016, UCM 109897, entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.

The guidance address the issue, as stated by FDA-CDRH, “In recent years, FDA has received an increasing number of 510(k)s for devices labeled as sterile that use sterilization methods other than the traditionally used methods”, i.e., novel sterilization methods.

A Novel Sterilization Method> is a method that FDA has not reviewed and determined to be adequate to effectively sterilize the device for its intended use.

  • Examples: Vaporized peracetic acid, High intensity light or pulse light, Microwave radiation, Sound waves, and Ultraviolet light

Established Sterilization Methods fall into two categories:

  • Established Category A have a long history of safe and effective use
    • Examples: Dry heat, EO with devices in a fixed, rigid chamber, Moist heat or steam, and Radiation (e.g., gamma, electron beam)
  • Established Category B have available published information on development, validation, and routine control
    • Examples: Hydrogen peroxide (H2O2), Ozone (O3), and Flexible bag systems (e.g., EO in a flexible bag system, diffusion method, injection method)