Compliance 2000

YEAR 2000 COMPLIANCE INFORMATION

The Federal Government has set up a World Wide Web site to provide information regarding the Year 2000 compliance of medical devices and scientific laboratory equipment.

Manufacturers of medical devices and biomedical equipment are urged to provide information regarding the Year 2000 compliance status of their products, including both current and previously manufactured products.

The Year 2000 compliant means, with respect to medical devices, that the product accurately processes and stores date/time data (including, but not limited to calculating, comparing, displaying, recording and sequencing operations involving date/time data) during, from, into and between the twentieth and twenty-first centuries, and the years 1999-2000, including correct processing of leap year data.

The intent is that for products to be Year 2000 compliant they must function as intended or expected, regardless of the date. A manufacturer’s reporting of Year 2000 compliance status should include all products (units) produced which could still be in service.

The FDA has a Year 2000 compliance form which could be obtained from their WebSite, http://www.fda.gov/cdrh/yr2000/y2kform.html using the USER ID = y2k and the PASSWORD = solution.

The FDA wants all manufacturers to certify that their medical devices are Year 2000 compliant or a certification that the date problem is not applicable to any of their products. The Certification can only be made if the manufacturer has assessed the compliance status of all products.

The FDA plans to post the certification or the non-compliance on their web site.

For more information please go to FDA WebSite as noted above.