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While its primary focus was device regulatory scope (FDA found the Exer Scan was marketed beyond the limits of its 510(k) exemption), the letter also enumerated major quality system deficiencies lack of design control procedures, no CAPA system, no complaint-handling SOPs, no auditing processes, etc

doi:10.1007/s00439-016-1652-z

So I definitely endured a lot of misunderstanding (from kids and adults)