Validating Off-the-Shelf Software

Originally Published MDDI February 2002

NEWS & ANALYSIS

James Dickinson

Medical device manufacturers need to validate any off-the-shelf software on which their products rely—with or without the software vendor's cooperation. So says FDA in a new draft guidance issued in January.

Moreover, the guidance says the agency expects device companies to ensure that the product development methodologies used by the software developer "are appropriate and sufficient for the device manufacturer's intended use of that . . . software."

The guidance recognizes that device companies may not be able to get access to the software developer's validation documentation, in which case it recommends that the device manufacturer perform sufficient system level "black box" testing to establish that the software meets their "user needs and intended uses." The guidance foresees that in many applications, black box testing alone will not be sufficient, and it hints that the manufacturer may then find that it cannot use off-the-shelf software.

In those instances where access to software vendor design and development documentation is possible, the guidance goes into detail on how the device manufacturer should validate the documentation. It even recommends auditing the design and development methodologies used by the vendor to construct the software. Furthermore, it says the manufacturer should also assess the development and validation documentation generated for the software.

"Such audits can be conducted by the device manufacturer or by a qualified third party," the document says. "The audit should demonstrate that the vendor's procedures for and results of the verification and validation activities performed [by] the OTS software are appropriate and sufficient for the safety and effectiveness requirements of the medical device to be produced using that software."

The full guidance, which replaces a 1997 document, may be reviewed at http://www.fda.gov/cdrh/comp/guidance/938.html.

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