Y2K readiness
This article was originally published in The Gray Sheet
Executive Summary
Confirmed in two separate FDA surveys of medical device manufacturers, one entitled "Report on the Evaluation of Manufacturers' Activities to Assess the Year 2000 Compliance Status of their Medical Devices," and the other entitled "Report on the Y2K Readiness Survey of Manufacturers of Essential Medical Supplies." FDA surveyed companies with a questionnaire about their Y2K readiness and followed up with audits of priority companies to confirm their information. The agency "is confident that the medical product industries are well prepared for the turn of the year," Commissioner Jane Henney comments in a Nov. 18 release. Audit findings are available at www.fda.gov/oc/y2k/