The FDA has released the first draft of a guideline for good manufacturing practices for computerized medical devices. The guideline will apply to the manufacturers of all computerized medical products, including computed tomography and magnetic resonance imaging.
The agency will determine whether to finalize the guideline after a period of industry comments. If the FDA decides to proceed, it will modify the guidance on the basis of those comments, said W. Fred Hooten, director of the FDA division of compliance programs, office of compliance and surveillance.
The guideline is called the "Application of the medical device GMPs to computerized devices and manufacturing processes--medical device GMP guidance for FDA investigators." Its purpose is to assist agency field operatives in their inspections of manufacturing facilities.
In addition to covering products, the draft guideline covers software and hardware intended to control automated device manufacturing processes, including quality assurance and record keeping. The guidance does not contain instructions on how to validate software.
"We would like to see the industry associations--HIMA and NEMA--develop some software validation guidance rather than our doing it," Hooten said. "They are the ones who are most knowledgeable in that area."
