The FDA is sticking with the foundation of its 1997 Guidance on 501(k) device modifications, with plans that follow device industry feedback, according to an article in The Gray Sheet. In a report submitted to Congress, the 1997 guidance is a “solid foundation and should remain mostly unchanged.”
This comes on the heels of the FDA’s 2011effort to develop a new guidance that attempted to revamp companies’ decision process for when a new 510(k) is necessary for product modification. There was great resistance from companies who argued it would lead to a big increase in the number of 510(k0 submissions required.
In the report to Congress, FDA says that while it plans to keep the main structure of the 1997 guidance, it will make some targeted revisions. They are as follows:
- Clarify key terms;
- Underscore importance of design verification and validation activities;
- Provide more guidance on when to submit a new 510(k) for changes to materials in a device;
- Provide up-to-date guidance on technological and regulatory advancements, updates in software and wireless devices;
- Ensure guidance document text is congruent with text in flowcharts.
The agency also says it plans to release separate draft guidance on 510(k) submissions for changes to device software. They want to ensure the manufacturers have up-to-date guidance on software and wireless devices.
The agency is also looking for feedback on how it can leverage its existing quality system requirements, saying it believes there may be other ways to use the information to reduce the pre-market burden manufacturers who must submit new 510(k) for modified devise.
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