FDA Issues Detailed Requiements for Device Reprocessors

Device reprocessors must adhere to new data requirements in their cleaning and sterilization methods, the FDA said in recent guidelines.

The FDA Sept. 25 issued a rule and guidance on reprocessed single-use devices (SUDs).
The rule, published as both a proposed and a direct final rule, updates information on reused devices that require premarket submissions, or 510(k)s.

The guidance details validation data requirements for reprocessed SUDs, which include cleaning, sterilization and functional performance data showing a reprocessed device is 'substantially equivalent' to the original device 'after the maximum number of times [it] is reprocessed as intended.'