What are the different labelling changes that require a new 510(k)

1. Medical Device Labeling Changes THAT REQUIRE A NEW 510(K) SUBMISSION

2. INTRODUCTION 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.

3. 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 effectiveness, they should still be evaluated for any potential impact. This evaluation may lead to a new 510(k) filing.

4. CHANGE FROM SINGLE-USE ONLY TO REUSABLE The risks associated with single-use and reusable medical devices can be significantly different. This is why when a manufacturer changes a device’s labeling from single-use to reusable, it is a must to get a new 510(k) submission processed. In case of this change, there are several new and different questions around safety and efficacy that need to be addressed, such as how effective are the disinfection or reprocessing steps that are employed for reusing the product, have these steps been fully validated utilising a contamination soil that may be equivalent to the one found in a clinical setting where the device is used, etc.

5. Changing labelling from Prescription (Rx) to Over-the-counter (OTC) use Any changes to a device’s usage instructions can greatly affect how safely and effectively users operate it. In most cases where the manufacturer makes a change from prescription-only (Rx) to Over-the- counter (OTC) the impact on its safety and effectiveness varies significantly, calling for a new 510(k) submission. As it must be evident, when there is a change from Rx to OTC, the target users operating the device are very different. Rx indication mostly comprises trained, experienced, or qualified healthcare professionals using the product, whereas OTC comprises layman users of different educational levels. Such a shift in indication raises several important questions around labeling comprehension and usability which are in turn related to the safe and effective use of the product. Thus, calling for a new 510(k) submission.

6. Changes that describe a new condition, disease, and patient demographic If a medical device is updated to address a new disease, condition, or patient group, a fresh 510(k) submission may be necessary. The FDA might see these changes as potentially impacting the device’s safety and effectiveness. For example, let’s say a device was previously approved for use in patients with stage 4 cancer, and now the manufacturer wants to expand its use to include stage 3 cancer patients. In this case, a new submission would be required. Such changes could introduce new risks or alter existing ones. Hence, doing a thorough risk assessment is essential.

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