Medical device lobby groups say they support the US Food and Drug Administration’s plan to align its Quality System Regulations (QSR) with the international quality system standard, but they want more than a year to make the transition.
In February, FDA published a long-awaited proposed Quality Management System Regulation (QMSR) rule to harmonize its regulatory requirements for medical device quality systems contained in 21 CFR part 820 with the international standard ISO 13485:2016. The agency said the move would help reduce the regulatory burden on manufacturers and save around a half billion dollars over 10 years. (RELATED: QMSR: FDA proposes QSR overhaul after years of delays, Regulatory Focus 22 February 2022)
While the medtech industry is overwhelmingly supportive of the move, several stakeholders have asked FDA for clarifications and more time in comments due to the agency by 24 May. They argue that the one-year transition period as proposed by FDA would be especially burdensome for smaller medtech manufacturers…
