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U.S. Department of Health and Human Services

Medical Devices

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Article in User Facility Reporting Bulletin: FDA is Seeking Comments and Suggestions on Labeling Reprocessed Single-Use Devices

This article was originally published in the Medical Device User Facility Reporting Bulletin, Issue No. 37, Winter 2001

FDA IS SEEKING COMMENTS AND SUGGESTIONS ON
LABELING OF REPROCESSED SINGLE-USE DEVICES

The Food and Drug Administration (FDA) plans to develop guidance on how reprocessed single-use devices (SUDs) may be labeled, including whether the original equipment manufacturer's (OEM) trademark or name should remain on the reprocessed device along with the identity of the remanufacturer (i.e., reprocessor). FDA invites comments and suggestions on the content of the guidance document. A notice entitled Medical Devices; Guidance on Labeling of Reprocessed Single Use Devices; Request for Comments and Information was published in the December 20, 2001 Federal Register.

Background

The Association of Disposable Device Manufacturers requested in a citizen's petition (March 22, 2001) that FDA:

  1. require reprocessors of SUDs to remove the OEM trademark from the devices and any reference to the OEM in the labels of the devices;
  2. take actions to identify and enforce this requirement; and
  3. refuse to approve premarket submissions (marketing clearance) unless the applicant represents that the device will meet this requirement.

On September 17, 2001, FDA denied the petition because it believed that any misleading implications from the OEM's labeling could be remedied by the reprocessor providing additional information about its responsibility for product problems. FDA also said that it would publish a guidance document that will recommend more specific language and directions on the matter.