Is a new 510k required for a modification to the device?
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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:
- Sterilization method
- Structural material
- Manufacturing method
- Operating parameters or conditions for use
- Patient or user safety features
- Sterile barrier packaging material
- Stability or expiration claims
- Design
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).
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Source ~ www.FDA.org
Source ~ www.FDA.org
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