FDAnews
www.fdanews.com/articles/156432-industry-patient-advocates-spar-over-need-for-510-k-s-for-modifications

Industry, Patient Advocates Spar Over Need for 510(k)s for Modifications

June 18, 2013
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