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.