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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
As described in 21
CFR 807.81(a)(3), a new complete 510(k) application is required for
changes or modifications to an existing device, where the modifications could
significantly affect the safety or effectiveness of the device, or the
device is to be marketed for a new or different indication.
When a 510(k) holder decides to modify an existing device, the holder must decide whether the proposed device modification(s) requires submission of a 510(k). It is not FDA's intent that a 510(k) must be submitted for every modification. However, all changes in indications for use require the submission of a 510(k). A change in indication for use includes prescription use to over the counter use. Deciding When to Submit a 510(k) for a Change to an Existing Device provides guidance to 510(k) holders on deciding when to submit a 510(k) for a change to an existing device.
Examples of modifications that may require a 510(k) submission include, but are not limited to, the following:
FDA believes that the 510(k) holder is best qualified to determine when modifications to their device could significantly affect safety or effectiveness. Therefore, every modification to the device should be reviewed by appropriate personnel to determine if it affects safety or efficacy. Any design or labeling change to a device should be evaluated and documented in accordance with the 21 CFR 820, Quality System regulation. If it is determined that the modification is not significant, the basis for this decision should be documented with supporting data in the 510(k) holder's device master file. If it is determined that the modification is significant, a new 510(k) must be submitted to FDA.
There are no provisions for a 510(k) amendment or supplement to the existing 510(k). A new 510(k) must be submitted. However, FDA developed a streamlined 510(k) process for modifications to a device cleared under 510(k), called the Special 510(k).
Deciding When to Submit a 510(k) for a Change to an Existing Device
http://www.fda.gov/cdrh/ode/510kmod.html
http://www.fda.gov/cdrh/ode/510kmod.pdfHow to Prepare a Special 510(k)
http://www.fda.gov/cdrh/devadvice/3144.html
Updated February 14, 2005
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