Deciding When to Submit a 510(k) for a Change to an Existing Device??   

Earlier this week, the FDA issued a new guidance regarding deciding when to submit a 510(k) for a change to an existing device which superseded the original guidance document released in 1997.  The new guidance has taken the original content and added crucial updates to ensure clarity on certain points to ensure that industry professionals and FDA staff consistently interpret the guidance.  This was done in hopes to make the process more transparent and make it more clear for manufacturers to decide when it is necessary to submit a new 510(k).

The guidance starts with one main flowchart that breaks down the process of deciding when to submit a new 510(k) for a change to an existing device into several categories.  Various different types of changes are addressed such as labeling changes and technology, engineering, performance, and materials changes, and a section solely devoted to In Vitro diagnostic (IVD) devices.  Each section breaks down the decision process using a flow chart which is followed up by a full description of each chart component in text form.  In addition to outlining the different types of changes that can be made to existing devices, the FDA also explains methods on how to assess risk due to changes in a device.

The appendixes of the guidance contain a wealth of useful information including examples of possible scenarios of deciding when it is appropriate to submit a new 510(k) for a change to an existing device, examples of sample documentation, and a glossary of significant terminology used throughout the guidance.

 

 

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