News!!! CALL FOR COMMENTS on the PROPOSED document on "Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions"


This document was developed by Work Group 2 of the AHWP to provide guidance and information to regulatory authorities (RA) and the medical device industry (Industry) on definitions, terms and classification of field corrective actions (FCAs) taken on marketed medical devices. If you have any comments, please send them to the AHWP Secretariat ( and copy to the AHWP WG2 Chair, Mr Yorkie CHOW ( on or before 31 Oct 2012.


Download file:AHWP-WG2-PMS-003 (19 Sep 2012).pdf