The FDA expanded validation data requirements for reusable medical devices

Risk of infection and inadequate performance are known concerns for reusable medical devices. In order to supervise the cleaning and sterilisation process of such devices, the FDA published a guidance in 2015 on validation and labelling requirements for reusable medical devices intended to be reprocessed in healthcare setting.

FDA has just updated the list of devices and design features for which a 510(k) should include instructions and validation data for the reprocessing process. The list includes 11 types of medical devices and their accessories (such as bronchoscopes, endoscopes and laparoscopic instruments). Validation data and instructions for reprocessing will need to be included in 510(k) submission from 8th August 2017.

The FDA notice can be consulted here, and the updated guidance here.