The FDA updated its draft guidance addressing when manufacturers should submit a 510(k) application for modifications of medical devices in the market, according to Med Device Online.
Here are five insights:
1. The updated guidance resembles the original 1997 FDA guidance, but clarifies certain submission aspects.
2. The guidance suggests manufacturers perform a risk-based assessment to see if a modification would impact the device's safety or effectiveness.
3. The updated guidance offers flow charts that pinpoint when manufacturers need to submit a new 510(k) for labeling, materials, technology, engineering and performance changes.
4. Manufacturers can also turn to the guidance to determine which device changes mandate a new 510(k) and which don't.
5. Not every modification will significantly impact a device's safety or require FDA review.