Regulatory Framework for Reprocessed Single-Use Devices

The practice of reprocessing devices that are intended for single use began in hospitals in the late 1970s. This practice has become widespread as a mechanism to save costs for healthcare facilities and reduce medical waste. Section 201(ll) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) defines the term ‘Reprocessed’, concerning a single-use device, as an original device that had previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition.

Reprocessors of single-use devices (SUDs) are held to the same regulatory requirements as the original manufacturer of the single use device. The FDA regulates reprocessed single-use medical devices to ensure their safety and effectiveness. 

Reprocessed SUDs should be capable of withstanding necessary cleaning, disinfection, or sterilization, and continue to comply with all applicable FDA requirements after each instance of reprocessing, up to the maximum number of times that the devices are intended by the reprocessors to be reprocessed. 

Regulatory Requirements Regarding Reprocessed Single-Use Devices

Reprocessed devices must meet the same regulatory requirements as the original manufacturer, including: 

• • Labeling requirements, including the statement “Reprocessed device for single use”; “Reprocessed by [the person or establishment responsible for reprocessing]” 
  • Premarket submissions, including 510(k) notifications and premarket reports, include validation data to demonstrate the device’s safety and effectiveness. Note that not all reprocessed devices require FDA review of premarket submissions, but those that do must meet specific requirements to ensure their safety and effectiveness notably devices that had required FDA review but did not have the option for reprocessing or 510(k) exempt devices where reprocessing may impact the safety and/or effectiveness profile of the device. 
  • Post market requirements, including medical device reporting, corrections and removals, and quality systems.  
  • Compliance with applicable FDA requirements after each instance of reprocessing, up to the maximum number of times intended by the reprocessor. 

The FDA also provides additional guidance on the applicability of statutory and regulatory requirements for reprocessed single-use devices. 

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