Only sterile medical devices require sterilization validation. Non-sterile medical devices may not fall under the sterility provision. For Sterility Information in Premarket Notification 510(k) Submissions for Devices Labeled as Sterile and Reprocessed Single-Use Medical Devices, the FDA issued two guidelines.
https://www.fda.gov/media/74445/download
https://www.fda.gov/media/71482/download