In a roundup of Medtech Insight’s most-read articles in May, the publication’s coverage of the US Food and Drug Administration’s (FDA’s) draft Quality Management System Regulation (QMSR) landed in the No. 1 slot.
In analyzing various stakeholder comments, partner Dennis Gucciardo told Medtech Insight that granting more than a year for industry to transition could signal that the QMSR isn’t as harmonized as the agency claims.
“You know, I've seen two, three years suggested. I think the hard part on that is, if FDA needs to make the case that ISO 13485 and the QSR are substantially similar, then why should they give companies a number of years to implement this rulemaking if they are, arguably, substantially similar? These are going to be interesting comments for FDA to respond to because the answer may cut against the agency’s argument that [the standard and the QSR] are substantially similar, if the compliance timeline is something drastic,” e.g., two or three years.
Subscription may be required.