I searched the FDA site and came up with useless results, my google-fu wasn’t any better.
Why are certain computer companies FDA approved and others not? (Dell and HP, respectively)
Why are certain operating systems approved and others not? (Win NT and Win 2003, respectively?)
What is the process and how long does it take for computer related items to go through the process?
The Food and Drug Administration is approving computers and software? Or is this another FDA?
Here in the hospital, certain Biomedical systems must meet FDA approval. Dell and WinNt are the only ones that those guys are allowed to use since those are the only products that meet approval on the vendors’ spec sheets. And it’s the FDA that i know about.
The FDA doesn’t approve computer companies. However, software that is part of a drug or medical device manufaturing process must be validated as part of the process validation, software that is a component of a medical device or is itself a medical device must go through the appropriate validation and verification requirements of the medical device regulations, and software used to maintain electronic records required by law or regulations must be 21 CFR part 11 complient.
And those of us who work in the very beginning of the drug pipeline (Drug Discovery) are quite pleased that our systems do not fall under the umbrella of Regulated Systems (a.k.a. GxP compliant: Good [Laboratory|Manufacturing] Practices). Once things move into areas such as clinical trials, everything must meet those very rigid guidelines.
As a consequence, computer applications used in Discovery tend to be more nimble and free flowing, closer on the spectrum to stuff you would see in an academic environment, while Clinical applications/hardware tend to be much more rigid and have been tested and documented to the hilt, more like what one might see in banking/financial systems.
Though this regulatory oversight exists for good reason, it makes it difficult to upgrade or enhance existing systems, so you find people using aging apps on fairly old technology, with warts and all, simply because those apps have already passed the rigorous requirements for a GxP compliant system.