Preparing Your Complaints/eMDR System for Upcoming FDA Mandate

May 18, 2015

By Sparta Editorial


The impact of poor product quality can be far reaching for a manufacturer.  High costs from returns, scrap and reprocessing combined with lost revenue and decreased customer retention comprise the direct risks of not managing quality effectively.  The cost of poor quality is further compounded when you include costs associated with expensive field corrections and product recalls.

To manage this risk and gain better visibility of quality issues, many leading companies are leveraging the complaint management process as part of a more comprehensive approach to quality management.  Complaints are a key source of quality data and integrating the complaint process with the quality management system enables a manufacturer to quickly identify problems and issue early quality alerts when products are not meeting there desired specifications.  As a result companies can move quickly to resolve quality issues in the market thereby minimizing potential costs of poor quality such as unanticipated service labor and parts costs.  Broadly, complaint information can be analyzed for trends and severity to identify where there might be a risk of recalls or an opportunity for product design improvement.   Moreover, gaining control of complaint data and linking it to quality management practices also further enables regulatory compliance.

Reporting to the FDA

One of the top 3 most frequent warning letter citations found in 2013 included Complaint files, specifically establishing and maintaining procedures for receiving, reviewing and evaluating complaints (21 CFR 820.198(a))*.  FDA requires manufactures to report product problems and adverse events to the FDA for Medical Devices.  A complaint management system has all the information that is needed for this type of reporting and can easily be adopted to manage submission processing using FDA’s MedWatch 3500A form. 

A key benefit to the automated form is the ability to include more valuable information on reporting as well as reporting more frequently.  This increases the transparency between both parties.  But the process can only be sustainable by FDA and manufacturer if using an electronic system to process the large volume of reports coming in.  For example, a current medical device manufacturer submits 25,000 MDR files annually to FDA which includes initial reports and supplemental reports.  If you multiply that by the number of manufacturers located in the US, you can easily understand the problem that the FDA has.  They can’t have personnel opening email or paper reports and sort and file those reports in a timely manner. 

This is a major reason why the FDA is transitioning to an electronic system.  With this new system in place, FDA can now accept Medwatch forms electronically and maintain the information in a central database.  Up until now, submitting MDR forms electronically has not been required.

Preparing your Quality System for Electronic Filing

Having reliable quality processes, systems and reporting infrastructures in place will facilitate effective and timely complaint management, especially as new legislation is created to better track and report adverse events.  Effective August 14, 2015, electronic submission of MDRs will be required to the FDA.

This new way of collecting data will help with the gathering and analyzing post market MDRs while minimizing data entry errors. eMDR submissions already have strict timeframe guidelines on how quick a manufacturer is required to report the eMDR based on when they were made aware of the problem.  Each of these data elements that are captured in your complaint intake, whether it’s integrated from another quality system, a CRM on-site or direct line from the hospital or doctor’s office,  need to provide information back in so reports can be created.  As long as there is a feeder to get those complaints, data and reports can easily be generated from the complaint system.

Implementing an automated global complaints process should be part of a company’s overall business strategy in order to effectively and efficiently track and monitor complaint handling performance.  The ability for a complaint handling system to communicate with a quality management system is essential for identifying if other facilities are having issues, communicating to leadership for continuous improvement and trending to prevent additional problems from occurring in the future.


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