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View Full Version : FDA requires 7 Years of Support? UL 544 for Extended Support? End of Life of Product


Pataha
3rd October 2005, 04:29 PM
Hi all,

Been looking on the FDA website for this reference. The company I have just moved to is doing some End of Life on some products. One of the customers asked what was our plan to continue to support this equipment under FDA requirements.

I do remember from the hospital side that we use to quote UL 544 for extended support, but I am unable to locate this clause on the FDA site.

Any advise, direction, or help would be greatly appreciated.

P.S. I do know that UL 544 is no more - that just how long ago I used it on manufacturers. Plus how does one edit the title, since it seemed to have expanded from my orginal?

Al Rosen
4th October 2005, 12:10 AM
Hi all,

Been looking on the FDA website for this reference. The company I have just moved to is doing some End of Life on some products. One of the customers asked what was our plan to continue to support this equipment under FDA requirements.

I do remember from the hospital side that we use to quote UL 544 for extended support, but I am unable to locate this clause on the FDA site.

Any advise, direction, or help would be greatly appreciated.

P.S. I do know that UL 544 is no more - that just how long ago I used it on manufacturers. Plus how does one edit the title, since it seemed to have expanded from my orginal?As far as I know, FDA does not have a requirement for this, only for records, which must be kept for the expected life of the device but not less than 2 years,.

Pataha
4th October 2005, 03:00 PM
That's what I thought. Is there a standard out there that defines the support beyond what the company defines it?