The FDA issued a final order reclassifying the active implantable bone conduction hearing system as a Class II device with certain special controls.
Clinical performance testing for the device must characterize any adverse events that occur during clinical use and implantation, and the testing must also demonstrate that the device serves its intended purpose under the anticipated conditions of use, the agency said.
Non-clinical testing, meanwhile, must demonstrate that the device performs as intended, including performance data that validates force output, mechanical integrity testing, and reliability testing that aligns with expected device life.
The device manufacturers must also conduct impact testing in a clinically relevant anatomical model. The FDA also instructs manufacturers to show that any components of the device making direct contact with the patient are biocompatible, and performance data must prove the components’ sterility as well as the shelf life of the device.
This data must also show the device’s wireless and electromagnetic compatibility as well as its electrical safety, and manufacturers must perform hazard analysis as well as software verification and validation.
Labeling for the device must include a summary of clinical testing that includes a rundown of any complications or adverse events, instructions for use and implantation, a shelf life for sterile components, a user manual and a patient identification card.
Read the final order here: www.fdanews.com/10-25-18-Device.pdf. — Zack Budryk