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(In general, the F.D.A. must sanction a medical device for a specific use before a company can market that use.
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The F.D.A. requires manufacturers to wait for federal clearance before marketing a medical device for specific uses.
This will enable the most appropriate transport system to be used as delivery device for a specific small molecule.
But Timothy A. Ulatowski, director of compliance at the Center for Devices and Radiological Health at the F.D.A., said companies were legally allowed to market a medical device only for the specific use for which it had been granted clearance.
"There needs to be some structure surrounding their use, so that the device has a specific targeted use," Kortum said in the email.
FDA can clear a specific device made by additive manufacturing for a specific intended use but it does not separately clear or approve raw material stock, final printed material or a printing process (e.g. Ti6Al4V using electron beam melting) for unspecified uses.
Kintera's functionless gadgets seem to capture how we desire to purchase new devices, not only for their specific use, but because they make us feel shiny and new.
Thus centres using volumetry in clinical practice or for studies may be familiar with the concept and a certain type of volumeter, but not with a specific device selected for a specific study.
If so, FDA provides clearance to individual devices for specific intended uses, not to materials for unspecified intended uses.
While the latter devices have focused on specific uses – extreme sports for example – Autographer and Memoto are more about capturing scenes from everyday life, as are the photography features in Google's Glass augmented eyewear.
This device uses a specific algorithm to identify if the sounds it picks up are gun shots.
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