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Medical Devices / Regulatory Affairs

FDA Considers Aligning QSR With ISO 13485

March 6, 2018

The FDA anticipates publishing a proposed rule early in 2019 on aligning Quality System Regulation, 21 CFR 820, with the international standards of ISO 13485:2016.

However, quality expert Dan O’Leary, president of Ombu Enterprises, notes that any changes to the existing regulation to help create closer alignment between the two standards would not simply replace QSR standards.

ISO is useful as an international standard, but there are elements of 21 CFR 820 that are considered better by some regulatory experts, such as the QSR requirements for complaint management and supplier management.

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