FDA classifies slew of class II devices following de novo procedures

Regulatory NewsRegulatory News | 04 January 2023 |  By 

Since the last week of 2022, the US Food and Drug Administration (FDA) announced it was classifying nine products as class II devices with special controls. The list of devices includes several software as a medical device (SaMD) products.
Between 23 and 30 December 2022, the FDA published half a dozen final orders announcing class II designations for devices and diagnostics products, which means sponsors can apply for those products using the agency’s less burdensome 510(k) pathway. The predicate devices for the products have been allowed on the market through its de novo authorization pathway over the past few of years, and four of the devices are SaMDs. The agency also issued classification orders identifying three devices as class II products during the first week of 2022: brain stimulation programming planning software, implantable post-surgical kinematic measurement knee devices and bone indentation devices.
The list of SaMDs includes gastrointestinal lesion software detection systems, pediatric Autism Spectrum Disorder (ASD) diagnosis aids, interventional cardiovascular implant simulation software devices and adjunctive hemodynamic indicators with decision point.
For each type of device the FDA noted certain risks and mitigations that sponsors can take to address them.
“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,” the agency said. “For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order.”
For instance, errors in the algorithm in gastrointestinal lesion software detection systems errors may risk outputting false positives and negatives that may lead to unnecessary treatments or delayed treatment. The FDA also noted that in many of the SaMD products, physicians may rely too much on the software when diagnosing patients.
To mitigate risks with potential algorithmic errors in gastrointestinal lesion software detection systems, the FDA says sponsors should perform and present clinical performance testing, and software verification, validation and hazard analysis. However, the most common mitigation steps the FDA recommends for SaMDs includes software validation and adding clear labeling so users understand the limitations of the products they are using.
Besides the SaMDs listed in the final orders, the FDA also issued final orders to classifying extracorporeal systems for carbon dioxide removal and resorbable implants for anterior cruciate ligament (ACL) injuries as class II devices with special controls.


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