“Inherently, complaints are just information—they’re pieces of information that come to FDA; they’re pieces of information that come to you as manufacturers,” according to Carl Fischer, Ph.D., director, Division of International Compliance Operations at CDRH. This may sound simple, but what does FDA do with them? Fischer offered a primer on complaints and how FDA categorizes them during the 2015 MedTech Intelligence Integrated Complaint Management conference in Washington, DC.
The definition section of CFR 820 defines complaints as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution”. In addition, CDRH’s Office of Compliance has an internal description of complaints.