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Home » Reliability and Risk Management for Devices
Reliability and Risk Management for Devices
July 19, 2022
Reliability is an important concept in medical device regulation. The FDA’s device regulation at 21 CFR 820.3(b) defines a complaint as an allegation of a deficiency in one or more of a long list of attributes, including reliability. And 860.7(b)(4), which specifies how device class and product codes are determined, includes reliability as a relevant factor in device classification. But the agency never defines the term within device regulations.