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Once a new medical device is in the market through a 510(k) clearance, itu2019s critical to continue monitoring changes to that device throughout its lifecycle and evaluating if any of these changes trigger a new 510(k) for the medical device.<br><br>
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Introduction Once a new medical device is in the market through a 510(k) clearance, it’s critical to continue monitoring changes to that device throughout its lifecycle and evaluating if any of these changes trigger a new 510(k) for the medical device. Various kinds of changes may be required to the device and often the inspiration may come from customer feedback, a complaint, a field trend, or simply to catch up with the updated technology. One common kind of change is the change in technology of the medical device.
Some technological changes to a medical device that likely trigger a new 510(k) 1. Control Mechanism Change The process by which the actions of a medical device are directed is termed as a control mechanism. Usually and mostly all the control mechanism changes significantly impact the device’s safety and effectiveness hence, calling for a new 510(k) submission. 2. Changes in the Operating Principles of a Medical Device Any change being introduced in the operating principles of medical devices can have a direct impact on the effectiveness and efficiency of a medical device, which would require a new 510(k) submission.
3. Changes in Energy Type If there are any changes introduced in either the output or input energy type, a new 510(k) submission is required. 4. Changes in the Sterilization Method If the sterilization method is changed in a medical device, as per the FDA a new 510(k) submission is necessary as the effectiveness and safety of the medical device will be impacted significantly, given the role sterilization plays in the safety of the device. It is essential to understand that the new sterilization method has no impact on the material or performance characteristics of the device.
5. Packaging or Expiration Date Changes In most cases, changes to device packaging or the expiration date don’t require submitting a new 510(k) to the FDA. Instead, the FDA relies on the Quality System (QS) regulations (21 CFR Part 820 or compliance to ISO13485) to ensure the continued safety and effectiveness of devices with these modifications. This applies whether the expiration date is based on packaging integrity, such as sterility, or the device’s finite shelf life.
