Single-Use & Reprocessed SUDs

Single-use devices

A single-use device (SUD) is a device intended by the manufacturer to be used on a single patient during a single procedure. Labelling must clearly indicate single-use intent.

Third-party reprocessing of SUDs

Despite single-use labelling, some SUDs are reprocessed and reused. FDA regulates third-party reprocessors of SUDs — entities that reprocess and sell reprocessed SUDs must comply with the same regulatory requirements as the original equipment manufacturer:

• Premarket submission (510(k) or PMA) as the reprocessor
• QMS (QMSR) compliance
• MDR reporting obligations
• Labelling as reprocessor (original manufacturer's name replaced)
• Registration and listing

Critical SUDs

For critical SUDs (those that contact blood, bone, or tissue), reprocessors must submit 510(k)s and demonstrate that the device can be adequately cleaned, disinfected/sterilised, and maintains its performance characteristics after reprocessing.

Official resources

• FDA — Reprocessing of Single-Use Devices
• FDA — List of Cleared/Approved Reprocessors

Examples of Critical SUDs

Critical single-use devices are those that contact sterile tissue or blood during use. Common examples include surgical instruments, implantable devices, and cardiovascular catheters. For critical SUDs, third-party reprocessors must demonstrate through 510(k) submission that cleaning, sterilization, and disinfection processes maintain device integrity and performance across multiple reprocessing cycles—typically validated through at least 10 reprocessing cycles or as specified in the original device's design specifications.