Applications for computerized devices must follow the appropriate CDRH guidance.124 Test data must support all performance and safety claims under routine and limited conditions.
Most laser and light-based devices have some element of software control. The FDA published the guidance on May 11, 2005 for software controlled devices: “Guidance for the content of premarket submissions for software contained in medical devices.”125 Components of software documentation may include hazard analysis, software description, and various device components under software control, architecture design chart, software requirements and specification, software design specifications, traceability analysis, and test plan for validation. In addition, it should be demonstrated that should the software fail or have a latent design flaw, the potential injury would not be considered life threatening, and would not result in permanent impairment of a body function.
Software marketed to enhance the performance of a device is regulated as an accessory to that device. If the software is designed to enhance the performance of a group of different devices, it is regulated as an accessory to the device in the group that poses the greatest risk to the user. Any instructions, prompts, or cautions displayed by the system are considered labeling, and must meet the labeling regulations.