MDR Guidance Clarifies Expectations for Complaint Investigations

July 19, 2013
Devicemakers seeking additional information about MDR reportable events should base the degree of their efforts on the nature and severity of the report, a draft FDA guidance says. The agency reminds manufacturers to make a “good faith effort” to get required information, adding that the lack of a returned device is not a free pass to not analyze an event.
Devices & Diagnostics Letter