FDA issues software guidance

The FDA has released the first draft of a guideline for good manufacturingpractices for computerized medical devices. The guideline willapply to the manufacturers of all computerized medical products,including computed tomography and magnetic resonance imaging.

The agency will determine whether to finalize the guidelineafter a period of industry comments. If the FDA decides to proceed,it will modify the guidance on the basis of those comments, saidW. Fred Hooten, director of the FDA division of compliance programs,office of compliance and surveillance.

The guideline is called the "Application of the medicaldevice GMPs to computerized devices and manufacturing processes--medicaldevice GMP guidance for FDA investigators." Its purpose isto assist agency field operatives in their inspections of manufacturingfacilities.

In addition to covering products, the draft guideline coverssoftware and hardware intended to control automated device manufacturingprocesses, including quality assurance and record keeping. Theguidance does not contain instructions on how to validate software.

"We would like to see the industry associations--HIMAand NEMA--develop some software validation guidance rather thanour doing it," Hooten said. "They are the ones who aremost knowledgeable in that area."