FDA Seeks Comments on SUD Guidance Document

Originally Published MDDI February 2002NEWS & ANALYSIS FDA is welcoming comments and suggestions concerning a guidance document the agency may issue on the labeling of reprocessed single-use devices (SUDs).

February 1, 2002

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FDA Seeks Comments on SUD Guidance Document

Originally Published MDDI February 2002

NEWS & ANALYSIS

FDA is welcoming comments and suggestions concerning a guidance document the agency may issue on the labeling of reprocessed single-use devices (SUDs).

FDA has not yet determined whether or not it will actually publish this guidance document, however. The notice was published in the December 20th, 2001, edition of the Federal Register.

The agency is soliciting comments that specifically address whether the name of the original manufacturer of the device should be removed from a reprocessed SUD and, in addition, whether the reprocessor's name should be placed on the device.

The deadline for written or electronically submitted comments is March 20, 2002.

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