Hello 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 the version and publication date so those match the Recognition Number. Though I find generally the reviewer knows which one is being addressed in the submission.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 05-May-2020 01:17
From: Anonymous Member
Subject: CDRH PREMARKET REVIEW SUBMISSION COVER SHEET
This message was posted by a user wishing to remain anonymous
Dear RAPS members,
I need some information on Utilization of Standards section of premarket coversheet.
There is a version column and date column in the Standard Utilization section of the coversheet. Which date is filled in the date column?
For example if we comply with 14971:2007/(R) 2010 as listed on FDA standards database then what do we write in version and date column of the premarket coversheet? Should this be documented as second edition for version and 2010 for date?
Thanks