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FDA issues draft updated recommendations on submitting a new 510(k) for device modifications

 
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FDA issues draft updated recommendations on submitting a new 510(k) for device modifications
by System Administrator - Wednesday, 10 August 2016, 5:36 PM
 

FDA issues draft updated recommendations on submitting new 510 (k) for device modifications

FDA issues draft updated recommendations on submitting a new 510(k) for device modificationsThe U.S. Food and Drug Administration today issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.

These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness

When finalized, the two guidances will provide improved clarity, regarding minor changes that do not require FDA review, and help ensure that the FDA receives appropriate submissions for modifications that do require premarket review by the agency.