FDA's new 510(k) modification rules look much like old ones

The FDA's proposed changes to the medical device 510(k) modification review process aim to clarify existing policy rather than change it.

Medical device makers lauded the FDA this week for policy proposals that would leave existing 510(k) modification rules generally intact, rather than pursuing the overhaul proposed 3 years ago.

Food & Drug Administration (FDA), AdvaMed

News Well, 510(k), 510(k) reforms, Food & Drug Administration (FDA), Regulatory/Compliance

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