Single-Use Device
A device the original manufacturer labels for one use or one patient, distinct from reusable devices and from FDA-regulated reprocessed SUDs.
Definition
A Single-Use Device (SUD) is one whose original-equipment manufacturer (OEM) labeling restricts it to a single use or single patient. The Medical Device User Fee and Modernization Act (MDUFMA) of 2002 created a separate regulatory pathway for third-party reprocessors of SUDs: they must obtain their own 510(k) clearance and comply with the same cleaning, sterilization, and functional-equivalence validation as OEMs. SUDs and reprocessed SUDs are a major sustainability and cost-pressure topic in hospital purchasing.What this means in practice
Reprocessed SUDs typically cut device cost 40-60% with no clinical performance difference when properly validated. FDA has cleared reprocessed versions of EP catheters, harmonic scalpels, and orthopedic burrs.- •Assuming OEM SUD labeling alone prevents a hospital from using a third-party reprocessor, it does not.
- •Ignoring environmental and Joint Commission scrutiny of single-use waste streams.
Related terms
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FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Activities to monitor device safety and performance after market release.
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Primary references
3 sources- 1
FDA, Reprocessing of Single-Use DevicesVerifiedFDAfda.gov
- 2
FDA Guidance, Reprocessing Medical Devices in Health Care Settings (2015)VerifiedFDAfda.gov
- 3
MedTech DiveVerifiedMedTech Divemedtechdive.com
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