On August 27, the FDA issued two draft guidelines intended to help strengthen and modernize the agency's 510(k) medical device program. Comments related to dental resins and facet screws must be submitted by October 29.
If the drafts become finalized, those who plan to submit a 510(k) for dental resins or facet screws must adhere to the performance criteria outlined in the document. The drafts support clearances based on substantial equivalence as opposed to direct comparison of the performance of an existing legally marketed device.
Furthermore, the agency encourages stakeholders to provide recommendations for additional types of devices that would benefit from inclusion in future guidance documents regarding performance and safety criteria.
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