All terms
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.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 9, 2026
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 the regulation says
FDA Guidance: 'Reprocessed Single-Use Devices: Termination of Exemptions from Premarket Notification' and the 2018 final guidance on reprocessing validation. 21 USC 360e (PMA) and 510(k) requirements both apply depending on device class.
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. Common pitfalls
- •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.
Primary references
3 sourcesLink health: 1 verified 2 bot-blocked· last checked 2026-05-09
FDA·2MedTech Dive·1
- 1
FDA — Reprocessing of Single-Use DevicesBot-blockedFDAfda.gov
- 2
FDA Guidance — Reprocessing Medical Devices in Health Care Settings (2015)Bot-blockedFDAfda.gov
- 3
MedTech DiveVerifiedMedTech Divemedtechdive.com
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