As a part of its Spring 2018 “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda), FDA recently issued a Notice of Proposed Rule Making (NPRM) that states by Spring 2019 FDA will propose a new rule replacing certain elements of QSR in 21CFR 820 with ISO 13485:2016. FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for the medical device manufacturer, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.
According to FDA Commissioner Scott Gottlieb, by amending and eliminating regulations that are ineffective, duplicative, and obsolete, the Administration can promote economic growth and innovation and protect individual liberty. The Agenda represents ongoing progress toward the goals of more effective and less burdensome regulation. This rule, if finalized, will harmonize domestic and international requirements and modernize the regulation to make it more efficient for manufacturers of medical devices seeking to sell their products globally, while also continuing to ensure they adhere to high, internationally-accepted quality systems.
Will this be good for the US medical device manufacturers – should be. Would this be good for the US Consumer – that is to be seen. As we all know the ISO audit is not like what an FDA audit is. Pass an FDA inspection by trained FDA investigators is just that in investigation and not an audit, like an ISO audit is.
Is the FDA going in the wrong direction for consumer protection for Global Harmonization as a response for reducing their budgeting for conducting device inspections? If the US FDA will start depending on audits like the new MDSAP and using third-party audits, then you can be sure there will be repercussions to this approach. We have written articles on the differences between ISO audits and the FDA audits. This has not changed and now with the MDSAP it will make the difference even greater. How could an inspection cover 5 a quality system like the ISO13485 and 5 countries inputs in a 4 or 5 day audit? There is no way it can be done unless it is an “audit” and not an investigation.
We are interested in seeing the FDA’s input and thoughts for “harmonizing” the QSR with the ISO. In reality, after conducting audits, inspections and being involved with both FDA and ISO audits for over 46 years, it should be ISO harmonizing with the QSR and not the other way around.
You need to remember, ISO is voluntary, the FDA QSR is legally required. Stay tuned.
