the software was used to validate genetic sequencers, hybridizer and amplifiers and other devices.
In order for a laboratory to be allowed to submit DNA sequencing results to court it has to be validated. Validated means that it can reliable reproduce the correct result. Often a drop of blood only provides enough material for on sequencing run the result better be right as this could send a person to prison.
The validation is a lengthy time intense process and the software we developed guided the laboratory with step by step instructions. (here the link to the software: http://marketing.appliedbiosystems....to_Landing
The FDA gets involved whenever a 'device' could put a human being at risk - this rule applied in this case as well. One of the regulations I can remember was CFR21 Part 11.