Category Archives: Get-The-Product-Out-In-Ones-Lifetime

FDA Approval of Medical Software?

I read a report recently about the US Food and Drug Administration (FDA) project involving the development of a regulatory scheme which may place computerized patient medical records systems, as well as the ancillary computerized medical devices that provide automated data collection, under the FDA’s scrutiny. The impact of such regulations being enacted is obvious. Critical time-to-market software development metrics would increase significantly, as would the cost of developing ‘free’ and Open Source software-based medical technologies such as diagnostic decision-support systems and computerized medical records systems.
Draft Revision of FDA’s Medical Device Software Policy Raises Warning Flags is a dated but comprehensive article that provides more background on this issue: ‘…Unless industry gets involved now, complex and prohibitive regulation looms on the horizon.’