According to the FD&C Act, FDA continues to collect the market updates and adopts the recommendations to modify the classification policy to match the market and technology requirements. In this regard, FDA received the request to re-classify the interoperable automated glycemic controller [1]. Eventually, on March 14, 2022, the new order for the modification of the Interoperable Automated Glycemic Controller classification has come into effect and the device is now classified as a Class II product.
Accordingly, FDA has identified the following risks presented in table 1 below, and provided suggestions for mitigating these risks:
Table 1: FDA summarizes the Interoperable Automated Glycemic Controller Risks and Mitigation Measures [1]
|
Identified Risks |
Mitigation Methods |
|
Risk due to data transmission interference/electromagnetic disturbance |
Certain verification and validation of electrical safety, electromagnetic compatibility, and radio frequency wireless testing. |
|
Failure to correctly determine the root cause of device malfunctions |
Certain verification and validation of logging capability |
|
Failure to correctly operate the device |
Human factors testing, User training plan, Compatible devices listed in labeling, and Certain warning statements and precautions in labeling. |
|
Risk due to insecure transmission of data |
Certain validation of communication specifications, processes, and procedures with digitally connected devices. |
|
Failure to provide appropriate treatment due to loss of communication with connected devices |
Certain verification and validation of risk control measures; and Certain validation of communication specifications, processes, and procedures with digitally connected devices. |
|
Risk of latent flaws in software |
Robust software validation testing; Certain validation of communication specifications, processes, and procedures with digitally connected devices; and Certain verification and validation of risk control measures. |
|
Failure to report device malfunctions or adverse events to the device manufacturer |
Plans and procedures for assigning postmarket responsibilities. |
|
Risk of connected devices having inadequate performance to allow safe use of the controller |
Specifications for performance of connected devices; Certain validation of communication specifications, processes, and procedures with digitally connected devices; and Limitations on interoperable devices. |
|
Risk due to lack of compatibility of connected devices |
Certain validation of communication specifications, processes, and procedures with digitally connected devices; and Limitations on interoperable devices. |
|
Risk due to the inability of the controller to handle different pharmacokinetic/pharmacodynamic characteristics of the drugs |
Clinical data demonstrating device performance, Drug compatibility information in labeling, User training plan, and Human factors testing. |
|
Risk due to poorer or different performance in pediatric populations |
Clinical data demonstrating device performance in pediatric population; and Certain contraindications, warning statements, and precautions in labeling. |
|
Patient harm due to inappropriate drug delivery |
Clinical data demonstrating device performance, Certain software validation testing, User training plan, and Certain drug compatibility information in labeling. |
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoiding automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is further subject to premarket notification requirements under section 510(k). For additional information, please kindly search for the respective Regulation Number 862.1356 to see the complete FDA requirements for the device [2].
References:
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Interoperable Automated Glycemic Controller
- Interoperable Automated Glycemic Controller – US FDA Product Classification