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U.S. Department of Health and Human Services

Medical Devices

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Definitions

Original Device: A new, unused single-use device.

Single-Use Device (SUD): A SUD is a device that is intended for one use or on a single patient during a single procedure.

Reprocessed Single-Use Device (SUD): A reprocessed SUD is an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient.

Supplemental Validation Submission (SVS): MDUFMA required that certain devices that had already been cleared through the 510(k) process are required to submit validation data regarding cleaning, sterilization, and functional performance in order to remain on the market. This additional data is referred to as a supplemental validation submission (SVS).  

Validation: Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

  • Process Validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
  • Design Validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).

Validation Data: Validation data includes cleaning and sterilization data, and functional performance data demonstrating that an single-use device will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification (510(k)).