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New 510(k) Reprocessing Guidance

Written by DTA Regulatory Consultant, Blix Winston.

The FDA has issued the final version of the reprocessing guidance for 510(k) submissions and provided a help helpful guidance webinar that you can watch at

The revised guidance contains must-have information if your 510(k) submission includes either sterile devices or devices that you intend the end user to clean and reprocess. Much of the discussion about this during a recent meeting between FDA and DTA centered on how FDA expects applicants to conduct validation of cleaning and sterilization processes. For example, FDA expects that two quantitative tests will be conducted for cleaning. Applicants should validate these tests to measure residual soil on your device, including negative and positive controls. Microbial log reductions should not be used to validate cleaning soiled devices. Soils appropriate to the environment in which the device is used should be considered.

The guidance is not retroactive but applies to submission received by FDA after Mar. 24, 2015.  Validation of cleaning and sterilization process should be treated independently in the submission.

One question at the meeting concerned cleaning agents. If your application recommends five different cleaning agents and three sterilization methods can be used, you should test all 15 combinations to validate that they work.