The FDA has classified continuous glucose monitor secondary displays, high throughput genomic sequence analyzers, and vibratory counter stimulation devices as Class II devices with special controls.
The agency has identified several potential health risks associated with glucose monitor secondary displays, including incorrect glucose values that could affect treatment recommendations. Special controls required by the agency include data protection measures and specified labeling requirements.
Genomic Sequencers: Inaccurate test data in high-throughput genomic sequence analyzers can produce health risks. As a result, these devices were classified into Class II with special controls, which include the development of analytical performance information for general validation testing.
Specialized testing equipment would be needed to show suitability for a specific use, such as hematology or oncology. The FDA also established labeling requirements for the devices.
Counter-Stimulation Devices: Vibratory counter-stimulation devices produce mechanical vibrations to improve the quality of sleep in patients with primary Restless Legs Syndrome. Health risks include pain and discomfort, electrical shock, burns, adverse skin reactions, and interference with other medical devices.
This device and others of its type were classified into Class II with special controls, including labeling requirements; testing to determine electromagnetic compatibility, electrical safety, and thermal safety; software validation; biocompatibility for components that contact the patient; and non-clinical performance testing.