cdrh RE: CDRH PREMARKET REVIEW SUBMISSION COVER SHEET By connect.raps.org Published On :: Wed, 06 May 2020 04:30:41 -0400 From : Communities>>Regulatory Open ForumHello Anon, In the version, I usually put the last year or the year generally recognised, e.g. ISO 14971 being 2007. Then for the publication date, I do put the latest version when published so would be April 2010. Because of the way standards are amended and revised, it can be quite difficult to determine what to put on the cover sheet. I would also rely a bit on the Recognized Standards list the FDA publishes: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm to list [More] Full Article Discussion