Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
Who it is for: clinic staff, buyers and students who meet the phrase “reprocessed” on a device label or a supplier quote. After reading you should be able to recognise a reprocessed single-use device, say who is responsible for it, and know which questions to put to a supplier.
What counts as a reprocessed medical device?
In U.S. law, a reprocessed device is a single-use device that was used on a patient, then put through additional processing and manufacturing so it can be used once more on a patient. The FDA quotes the Federal Food, Drug, and Cosmetic Act (section 201(ll)): a single-use device (SUD) is “a device that is intended for one use, or on a single patient during a single procedure”, and a reprocessed SUD is “an original device that has previously been used on a patient and has been subjected to additional processing” so that it can be used once more on a patient.
Who uses them: hospitals and other health care facilities that buy from third-party reprocessors, and facilities that reprocess their own single-use devices. The FDA says reprocessing in hospitals began in the late 1970s. Not every single-use device is a candidate: the FDA states that “some SUDs may not be suitable for reprocessing.”
How can you tell a device has been reprocessed?
Look at the label. Under section 502(v) of the FD&C Act, a reprocessed SUD must carry the statement “Reprocessed device for single use. Reprocessed by [the person or establishment responsible for reprocessing]”, in addition to the generally applicable device labeling requirements. The name in that statement identifies the party responsible for the reprocessing, which is not necessarily the company that made the original device.
Who is responsible for a reprocessed device?
The reprocessor. The FDA regards third-party reprocessors, including health care facilities that reprocess single-use devices, as manufacturers. They must comply with the statutory and regulatory requirements that apply to manufacturers, including:
- the Quality System Regulation (21 CFR Part 820);
- Medical Device Reporting (21 CFR Part 803);
- registration and listing (21 CFR Part 807);
- labeling (21 CFR Part 801);
- premarket notification or approval where required (21 CFR Parts 807 and 814).
The FDA describes this as regulating reprocessors “in the same manner as the original equipment manufacturer (OEM).”
Critical, semicritical and noncritical: what the tiers mean
The FDA uses three categories for reprocessed SUDs, as set out in the FDA reprocessed SUD FAQ.
| Tier | Definition (FDA) | Source |
|---|---|---|
| Critical | Intended to contact normally sterile tissue or body spaces during use | FDA reprocessed SUD FAQ, Q7 |
| Semicritical | Intended to contact intact mucous membranes and not penetrate normally sterile areas of the body | FDA reprocessed SUD FAQ, Q7 |
| Noncritical | Intended to make topical contact and not penetrate intact skin | FDA reprocessed SUD FAQ, Q7 |
The tier tells you what the device is intended to touch. The FDA also notes that whether a premarket submission is needed depends on the device’s original classification and exemption status, so the tier alone does not say which paperwork exists.
Single-use, reprocessed and reusable: where the line falls
| Question | Original single-use device | Reprocessed single-use device |
|---|---|---|
| Intended use | One use, or one patient during one procedure | An additional single use on a patient after processing |
| Who is the manufacturer | The original manufacturer | The reprocessor is treated as a manufacturer |
| Required label | Generally applicable device labeling | Generally applicable labeling plus “Reprocessed device for single use. Reprocessed by …” |
| Premarket evidence | As required for the device | Validation data for certain devices, including cleaning, disinfection or sterilization and functional performance, up to the maximum number of reprocessings the reprocessor intends |
Sources: FDA, Reprocessed Single-Use Devices: Frequently Asked Questions; FDA, Reprocessing Single-Use Medical Devices: Information for Health Care Facilities (both content as of 1 August 2024, checked 1 November 2026).
Single-use versus reusable starts with the manufacturer’s intended use: the FDA’s single-use definition turns on the device being “intended for one use.” A reprocessed device remains a single-use device that has been processed again; it is not the same thing as a device designed and labeled for reuse. For a worked example of the single-use question on a specific product class, see autoclavable vs single-use surgical instruments and disposable bronchoscopes.
What evidence sits behind a reprocessed device?
For certain Class I and Class II reprocessed SUDs, a 510(k) must include validation data, including functional performance data, showing the device remains as safe and effective as the predicate after the maximum number of times the reprocessor intends to reprocess it. For Class III reprocessed SUDs, a premarket report carries the same kind of data. The FDA expects reprocessors to demonstrate that the device can be adequately cleaned and disinfected or sterilized, that its physical characteristics or quality are not adversely affected, and that it continues to comply with applicable FDA requirements. Not all reprocessed SUDs need premarket review; whether one is needed depends on the device type.
What to ask a supplier for
The FDA does not publish a buyer’s checklist. The table below is an editorial cross-walk: each question follows directly from a requirement the FDA states for reprocessors.
| FDA requirement | Question this suggests | Source |
|---|---|---|
| Reprocessed label statement (FD&C Act 502(v)) | Does the device label carry “Reprocessed device for single use. Reprocessed by …” and name the reprocessor? | FAQ Q5 |
| Reprocessor treated as manufacturer | Which company is the reprocessor, and is it registered and listed with the FDA (21 CFR Part 807)? | FAQ Q6 |
| 510(k) or premarket report where required | Does this device type need premarket review of its reprocessing data, and which submission covers it? | FAQ Q2, Q4 |
| Maximum number of reprocessings | What is the maximum number of times the reprocessor intends this device to be reprocessed? | FAQ Q4 |
| Quality System Regulation and Medical Device Reporting | Who receives and reports adverse events and corrections for this device? | FAQ Q6 |
For label identifiers on the device itself, see UDI labels. For the wider regulatory picture, see medical device reprocessing, and for buying devices that are not new, used medical supplies.
Common mistakes
- Treating “single-use” and “reprocessed” as opposites. A reprocessed device is a single-use device that has been used and processed again.
- Assuming the original manufacturer’s name on the product identifies who is responsible. The reprocessing statement names the responsible party.
- Assuming every single-use device can be reprocessed. The FDA states some are not suitable.
- Assuming one tier means one regulatory route. Premarket requirements depend on the device’s original classification and exemption status.
Frequently asked questions
Is a reprocessed medical device the same as a single-use device?
No. It is a single-use device that was previously used on a patient and then processed again for one more single use, under the FDA definition in section 201(ll) of the FD&C Act.
How do I know whether a device is reprocessed?
It must be labeled “Reprocessed device for single use. Reprocessed by” followed by the responsible person or establishment (section 502(v)).
Is there a limit on how many times a device can be reprocessed?
Yes. For devices that need a 510(k) or premarket report, the validation data must cover the maximum number of reprocessings the reprocessor intends.
Are hospitals that reprocess their own devices regulated?
Yes. The FDA treats health care facilities that reprocess single-use devices as manufacturers.
Where can I ask the FDA a question?
The FDA’s page for health care facilities directs questions to its Division of Industry and Consumer Education (DICE).
Sources
- FDA, Reprocessed Single-Use Devices: Frequently Asked Questions, content current as of 1 August 2024, checked 1 November 2026.
- FDA, Reprocessing Single-Use Medical Devices: Information for Health Care Facilities, content current as of 1 August 2024, checked 1 November 2026.
