Hello Shikha,
This depends on whether the form, function, and operation of the medical device is affected by the change to the accessory. Without knowing the device, the accessory, or the type of change, it is hard to say, but I refer you to the FDA Guidance document for when to complete a 510(k) for an existing device. If you go through the flowchart and read the descriptors for each there is the item B.5 and then the sub-boxes 1 through 4. There is the question whether a change to accessory would alter the use of the device. Specifically if you go down to the paragraph "Components and accessories" which says 'manufacturers should consider whether changes to the device or any of its components or accessories affect the use of other components or accessories, or if changes to a component or accessory could lead a device to be used in a new way.' So yes, depending on the change you are making to your accessory it might require a new 510(k) for the main medical device.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-May-2020 10:47
From: Shikha Malik
Subject: 510(k) accessories
Hello,
If there is a significant change to an accessory cleared under a 510(k) of a product, are we supposed to file a significant change to the FDA for the original 510(k) for the accessory?
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Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
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