Living Innovation Blog
A blog about important topics for medical device and healthcare innovators.
Home-Use Medical Devices: FDA Workshop
A few weeks ago I attended a workshop convened by the FDA as they begin the process of drafting a document for the FDA titled “Medical Device Home Initiative." The purpose of the workshop was for the FDA to gather industry opinion in helping them with future definition of Home Medical Devices. The workshop was well attended by human factors consultants as well as large medical device companies who are concerned about how future regulations will guide them.
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Posted on Feb 25, 2011
Expediting FDA Approval with Human Factors Usability Testing
It seems that each day we are receiving more signals from the FDA that they are increasingly taking medical device usability testing seriously. Very seriously. The agency is asking for usability testing early and often, and is expecting manufacturers to collect sound data in order to support the claims of safety and efficacy that they are making in their device applications. Having sound protocols for such data collection is intended to help speed regulatory approval of new medical devices.
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Posted on Feb 07, 2011