Partner Dennis Gucciardo spoke to Medtech Dive about the structure of the Food and Drug Administration’s (FDA’s) new proposed rule, which adopts an international standard for US quality system regulations. The FDA incorporating the international standard by reference with add-ons where it didn't meet US standards—rather than making changes to the existing US regulations—could make it easier for the agency to incorporate future alterations to the international standard, Dennis told the publication.
In regard to the new standards and FDA investigations, Dennis said companies should not have a false sense of security. "I think there's going to be some interesting findings, in terms of things that notified bodies would let go, FDA's not going to let go,” he said.