FDA Received over 2 Million MDRs in 2021

The Coronavirus pandemic did not stop the growth of MDRs reported to the Food and Drug Administration. The long term trend of 20% annual growth has continued in 2021. Over 2 Million MDRs (Adverse Events or serious malfunctions) were reported to the FDA. This is staggering as the number was only 300,000 in 2010.

The Increase in Volume of Complaints and MDR reports

In the past 10 years, the number of MDRs reported to the FDA has skyrocketed. In 2010, the number of submitted complaints was 337,838. In 2021, it had increased to 2,028,399. With the exception of 2016, the number of complaints filed increased by 20% each year. A conservative estimate shows that 1% of all complaints are MDRs, meaning that there are over 200 million complaints filed annually.


MDRs increasing annually

Picture 1 – MDRs by Year.  2010-2021


Picture 2 – MDRs by Year.  2010-2021

Compliance and Financial Costs of Post Market Surveillance

A high volume of complaints and MDRs have very pronounced implications for businesses. Handling complaints and MDRs is a complex process that must go through many voluminous stages necessary for their closure (Intake, Complaint Evaluations, Investigations, and Root Cause Analysis as well as Regulatory Reporting). The necessity of painstakingly reviewing MDRs and complaints means there is less time for companies to evaluate product performance, help R&D with new product development, and better communicate with Regulators.

Managing complaints on its own is not cheap; it costs the industry tens of billions of dollars per year. Depending on the device, the money a company may spend on a single MDR can be as high as $2000. These are unsustainable numbers, especially with the cost pressures of both government and private insurance.

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About Smarteeva:

Based out of Santa Barbara, CA. Smarteeva Software provides cutting edge and innovative Post Market Surveillance applications for the Medical Device industry. Smarteeva’s Complaint Handling, Adverse Event Reporting, Risk Management and Recall Management solutions prioritize compliance, organizational efficiencies and user friendliness. Built on the Salesforce.com Platform and utilizing the latest innovations in AI and Machine Learning, Smarteeva Software provides a true partner to it’s business users.