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Home » U.S. Won’t Expand 510(k) Modification Policy, Sticks With 1997 Guidance
U.S. Won’t Expand 510(k) Modification Policy, Sticks With 1997 Guidance
Medtech companies that make modest improvements to their products will, in most cases, not need to file a new 510(k) with the U.S. Food and Drug Administration, a Feb. 25 report to Congress says.
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