Home » Industry, Patient Advocates Spar Over Need for 510(k)s for Modifications
Industry, Patient Advocates Spar Over Need for 510(k)s for Modifications
Industry’s case against significant reforms to the FDA’s policy on when devicemakers must submit a new 510(k), made during a Thursday public meeting, drew pushback from consumer groups that argued current controls don’t ensure patient safety.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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