Changes to Software

Example

Category (Significant, non-significant)

Change to software which impacts the control of the device that may be alter diagnostic or therapeutic function, such as:

  • Software change causing the change of critical steps for laser delivery on eye treatment.

Significant
Change to software initiated by manufacturer that modifies the algorithm that affects the diagnostic or therapeutic function, such as: 

  • An X-ray Lung Nodule Assessment Software is used along with a Digital Radiography System to support physicians in the visualization, identification, evaluation and reporting of pulmonary lesions/nodules in chest images. An algorithm change improves the detection rate for small nodules.

Significant

Change to software with addition of new features or software applications that affect any diagnostic or therapeutic functions of a medical device, such as:

  • Insulin Pump - Software changes that allow for wireless communication with compatible (continuous) blood glucose monitors.

Significant
Change to software that includes addition or removal of alarm function, such that a response to this change affect the treatment of patient, such as:

  • Electrocardiogram Addition to software of an early warning alarm to signal a potential cardiac event such as atrial fibrillation.

Significant
Change to software that affect the safety and performance of the registered medical device such that treatment or diagnostic of the patient is altered, such as:

  1. Blood Oxygen Monitor - A software change that allows the monitor to report blood CO2 concentrations with higher accuracy up to 0.5% deviation.
  2. Upgrade of software version changes the performance characteristics like specificity or sensitivity of the In-vitro diagnostic medical device.

Significant
A simple bug fix to correct the display error on the data table from the software analysis result.

Non - Significant
Change in software which only introduces non-therapeutic and non- diagnostic features such as printing, faxing, improved image clarity or reporting format.

Non - Significant
Change in software to disable certain functions that does not interact with other functions.

Non - Significant
Change to software incorporating a change to the operation system platform, such as:

  • A change in the software together with operating system change from Linux to another operating system platform.

Non - Significant
Addition, change, and deletion of OS version(s) (operating environment) within the same platform such as:

  • When Windows X is added for a product for which Windows 7 is specified as an OS.

Non - Significant
Change in software to alter colors and location of menu on graphic user interface of medical devices that does not affect safety and performance of the device but results in version change.

Non - Significant
Change in software to add languages for users that does not accompany changes in the main features and misunderstanding in translation for intended use, principle of operation, and performance.

Non - Significant
Change in the distribution/storage method of software among physical media (USB, CD, DVD), digital means (download), etc.

Non - Significant
Change in software to strengthen the cybersecurity such as:

  1. Adding encryption to the configuration file of the device,
  2. Adding passcode requirements for remote users, in addition to the password needed to access the device; and
  3. Adding a timeout for remote user or changing the access of the restricted user/customer to appropriate levels.

Non - Significant
Change in software to disallow use of the specific characters that are invalid as defined in the instrument host interface specification for the prevention of Specimen Identification (ID) barcode information truncation.

Non - Significant
Change in software to return the system into specification of the most recently cleared device regarding DICOM(Digital Imaging and Communications in Medicine standard; http://dicom.nema.org/) conformance allowing the automatic fetching of prior studies from radiology information system using PACS (Picture Archiving and Communication System).

Non - Significant
Change in software to correct the bottle size parameter of the cleaning solution to prevent the fluid detection errors.

Non - Significant
Change in IVD analyzer software to ensure new data of the administrative records for reagents is not merged with the existing data in the table within the software by correcting software code in the control unit of the analyzer to modify the table to add new columns.

Non - Significant
Change in IVD analyzer software to rewrite an incorrectly worded software requirement and to modify code in the control unit of the analyzer without modifying the core algorithm (such as detection or measurement module algorithm).

Non - Significant
Changes in software including the addition of product indication for use or its operating principles including diagnostic algorithm such as machine learning that may alter diagnostic or therapeutic function.

Non - Significant
Change in accuracy of Machine Learning Medical Device software via modification and expansion of the training dataset without any changes to labeled product design specification.

Non - Significant