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U.S. Department of Health and Human Services

Medical Devices

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Article in User Facility Reporting Bulletin: "Using Standards in Premarket Submissions for Reprocessed Single-Use Devices"

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

USING STANDARDS IN PREMARKET SUBMISSIONS FOR
REPROCESSED SINGLE-USE DEVICES

Standards may be as useful in premarket notification (510(k)) submissions for reprocessed single-use devices (SUDs) as they are for 510(k)s from original equipment manufacturers. The following documents explain FDA's policy about the use of standards.

Standards recognized by FDA that may be useful to reprocessors of single-use devices, such as those for sterilization, biocompatibility, and safety/performance, can be found by searching the Standards web site at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.