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There are several reasons why medical devices are modified once they are on the market. Although many types of changes happen in medical devices, today, our focus will be primarily on medical device labeling. <br><br>Before we proceed, letu2019s understand one thing u2013 not all labeling changes would need a new 510(k) submission. It is the responsibility of the medical device legal manufacturer to assess and understand whether the labeling changes he intends to make call for a new submission. This assessment is primarily based on understanding the impact of the change against the 510(k) clearance thatu2019s
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ELEXES MEDICAL DEVICE LABELING CHANGES THAT REQUIRE A NEW 510(K) SUBMISSION www.elexes.com
ELEXES There are several reasons why medical devices are modified once they are on the market. Although many types of changes happen in medical devices, today, our focus will be primarily on medical device labeling. Before we proceed, let’s understand one thing – not all labeling changes would need a new 510(k) submission. It is the responsibility of the medical device legal manufacturer to assess and understand whether the labeling changes he intends to make call for a new submission. This assessment is primarily based on understanding the impact of the change against the 510(k) clearance that’s already been obtained for the medical device. www.elexes.com
What are the different labelling changes that require a new 510(k) Any Change that significantly impacts the safety and effectiveness of the medical device If a manufacturer makes any changes to a device that could significantly impact its safety and effectiveness, a new submission will be required. Even if the changes aren’t intended to affect the device’s safety or @elexes effectiveness, they should still be evaluated for any potential impact. This evaluation may lead to a new 510(k) filing.
TO CONCLUDE Medical devices often undergo various changes in design, functionality, clinical application, and materials due to process improvements, supply chain adjustments, or technological advancements. Many of these changes result in changes to device labelling. Each change must be reviewed and approved and might undergo the change control process, which is typically a part of the medical device’s quality management system. Changes also need to be assessed for their impact via an impact assessment exercise. In the United States, any major modifications in the labelling that could impact a cleared device’s safety or effectiveness typically require a new 510(k) submission. www.elexes.com
