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.
- Use of Standards in Substantial Equivalence Determinations explains how consensus standards may be used in 510(k)s including those for reprocessing of SUDs.
- Recognition and Use of Consensus Standards; Final Guidance for Industry and Staff provides guidance to FDA staff and industry on the recognition and use of national and international standards, including declarations of conformity to these standards during the evaluation of all premarket submissions.
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.