US QSR Revision Plan For Harmonization To ISO 13485


“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 medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and record keeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.” stated by US FDA.

The FDA Commissioner Scott Gottlieb shared in the FDA blog post on 9 May 2018 that “As part of our efforts to continue to ensure efficiency of existing regulations, we will be taking another step to modernize medical device regulation, by proposing a new regulation to replace certain aspects of existing Quality System regulations with specifications of an international consensus standard for medical device manufactures (ISO). 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.”

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