Complaints and Complaint Investigations

Complaints and Complaint InvestigationsPresented by:Graham N. Giesen, Supervisory InvestigatorFood and Drug AdministrationOffice of Regulatory AffairsDallas District OfficeDefinition: ComplaintAny 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 distribution21 CFR (b) Complaint Files & Procedures Maintain Complaint files Establish and maintain procedures for receiving, reviewing, and evaluating Complaints by a formally designated unit Process all Complaints in a uniform and timely manner Document oral Complaints upon receipt21 CFR (a)The Preamble on Documenting Oral ComplaintsA December 1986 General Accounting Office report entitled Medical Devices: Early Warning of Problems is Hampered by Severe Underreporting, ..showed that approximately 83 percent of the hospitals report Complaints orally. FDA believes that these oral Complaints must be captured in the Complaint handling Preamble, Comment 191 MDR Reportable ComplaintsEvaluate Complaints to determine whether the Complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting21 CFR (a)(3) Complaints Not Investigated Review and evaluate all Complaints to determine whether investigation is necessary When no investigation is made, maintain a record that includes the reason

Complaints and Complaint Investigations Presented by: Graham N. Giesen, Supervisory Investigator Food and Drug Administration Office of Regulatory Affairs

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