According to the FD&C Act, the FDA continues to collect market updates and adopts recommendations to modify the classification policy to align with market and technology needs. In this regard, the FDA received a request to reclassify the Interoperable Automated Glycemic Controller. Ultimately, on March 14, 2022, the new order modifying the classification of the Interoperable Automated Glycemic Controller took effect, and the device is now classified as a Class II product.
Identified Risks and Mitigation Measures
The FDA has identified various risks associated with the device, as summarized in the table below, along with suggestions for mitigating these risks:
| 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 devices | Human factors testing, user training plan, compatible devices listed in labeling, and certain warning statements and precautions in labeling. |
| Risk due to insecure transmission | Certain validation of communication specifications, processes, and procedures with digitally connected devices. |
| Failure to provide appropriate communication with connected device | 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 post-market 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. |
The FDA has determined that special controls, in combination with general controls, address these health risks and provide reasonable assurance of the safety and effectiveness of the device. For a device to fall within this classification and avoid automatic classification as Class III, it must comply with the special controls mentioned in this final order. These necessary special controls are codified in the regulation associated with this order. Additionally, this device is subject to premarket notification requirements under section 510(k). For more information, please review Regulation Number 862.1356 for the complete FDA requirements for the device.
References
- FDA Classification - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=700
- Federal Register Notice - https://www.federalregister.gov/documents/2022/03/14/2022-05303/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the
Type Approval Impacted: Medical
Date Published: 04/27/22
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |