In today’s fast paced society, innovation and progress are the name of the game, especially in the medical device industry. However, placing so much pressure on the development of new technology puts resolving issues associated with products, already on the market, at risk of dropping to the bottom of management’s priority list. Manufacturers are required to investigate and correct problems with existing products according to FDA complaint handling regulations. In addition to maintaining regulatory compliance, proper complaint handling helps manufacturers utilize post-marketing activities for continuous improvement of product quality, initiate new product development, and reduce non-compliance risks . Despite the regulatory requirements and benefits of handling complaints, manufacturers are falling short in this area. In 2014, the FDA cited 423 21 CFR 820.198 violations, and in recent years at least 65% of warning letters contain complaint handling citations [2, 3]. The number of high complaint handling citation rates raises the question: What common violations are manufacturers committing? The top three issues the FDA finds regarding complaint handling are:
- Inadequate procedures, or not following procedures, for receiving, reviewing, and evaluating complaints
2. Failure to close out complaints in a timely manner
3. Disconnect between complaints with adverse events and Medical Device Reporting (MDR) requirements .
To improve upon these issues, this two-part blog series will break down FDA regulations for complaint handling into the basic requirements to help manufacturers move toward uniform, timely, and appropriate complaint handling.
The specific regulations for complaint handling are documented in 21 CFR 820.198. The most basic requirement for manufacturers is that they must maintain complaint files . The regulation does not define a specific file system; it is up to the manufacturer to implement a file system suitable to its needs. The complaint files may be paper-based, electronic, or a mixture of both formats, as long as the files are accessible to the manufacturing establishment. A formal complaint handling unit must be established for receiving, reviewing, and evaluating complaints according to the manufacturer’s established procedures. These procedures are to ensure that complaints are reviewed in a uniform and timely manner, all oral complaints are documented upon receipt, complaints are evaluated to determine whether an investigation is required, and if the complaint needs to be reported to the FDA under 21 CFR 803 as a MDR .
Before diving into MDRs, let’s discuss the fundamental components of a complaint file and investigation. Each complaint file should include the name of the device, date the complaint was received, complainant name and address, nature and details of the complaint, and the unique device identifier (UDI) or universal product code (UPC) and any other device identification(s) and control number(s) [5,6]. Upon receipt of a complaint, the complaint handling unit must evaluate it to determine whether an investigation is warranted. If it is determined that an investigation is not necessary, the manufacturer must retain a record with the reason why no investigation was conducted and the name of the individual who made the decision . In the event that the complaint evaluation indicates an investigation is required, the complaint handling unit must create an investigation record. The investigation record will contain the information collected in the initial complaint file, as well as dates and results of the investigation, any corrective action taken, and any reply to the complainant . An investigation is required under 21 CFR 820.198 if the complaint involves the possible failure of a device, labeling, or packaging to meets its specifications. However, if an investigation has already been performed for a similar complaint, another investigation is not necessary. During the investigation, the complaint handling unit must conclude whether or not the event triggers a MDR.
Back to Basics: Complaint Handling – Part II will address MDRs in more detail. We will review what events are considered MDRs, how different locations report MDRs to the FDA, the 3 types of reports manufacturers may submit to the FDA, as well as how the public can access MDRs.
- Singer, N. Handle Complaints Effectively. Medical Device Summit. 2010. Available from: http://www.medicaldevicesummit.com/RegulatoryCompliance/Features1/Handle-Complaints-Effectively-116.aspx.
- FY 2014 Inspectional Observation Summaries. FDA. 2014. Available from: http://www.fda.gov/ICECI/Inspections/ucm424098.htm#Devices.
- Heyl, M. Complaint Handling and Medical Device Reporting Where Inspectors Look First. FDAnews 2014. Available from: http://www.fdanews.com/complainthandlingondemand.
- Thompson, H. Streamlining Complaint-Handling Process. Medical Device and Diagnostic Industry. 2010. Available from: http://www.mddionline.com/article/streamlining-complaint-handling-process.
- 21 CFR 820.198 Complaint Files, FDA, Editor. 2014.
- MedmarcStaff. Complaint Handling for Medical Device Manufacturers. Medmarc. Available from: http://www.medmarc.com/Life-Sciences-News-and-Resources/Risk-Management/Pages/Complaint-Handling-for-Medical-Device-Manufacturers.aspx.
- Xiao, A. Complaint Handling and Medical Device Reporting (MDRs). FDA. 2013. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusines