FDA issues Guidance Document - Benefits-Risks Factors to consider for 510(K)

#1
The benefit-risk factors discussed in this guidance may assist FDA reviewers in making substantial equivalence determinations and may help accommodate evolving technology during the 510(k) premarket process.

This guidance may also help submitters of 510(k) premarket notifications demonstrate substantial equivalence in their premarket submissions. FDA has developed this guidance in order to improve the predictability, consistency, and transparency of the 510(k) premarket review process.

This guidance does not change the 510(k) premarket review standard or create extra burden on a submitter of a 510(k) to provide additional performance data from what has traditionally been submitted during the review process for 510(k) submissions.

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