Medical Device Recalls: New FDA Data is Not What You’d Expect!

A new report from Northeastern University has shed some light on the top reasons for medical device recalls in the last five years. Previously, the FDA had been working from a report covering the fiscal years 2003-2012, but this new report that covers 2013-2018 suggests that updating is in order.

Medical device manufacturers intent on adhering to all regulatory requirements in order to avoid product recalls should pay close attention to the report in preparing their quality systems and risk management planning. The graduate students working on the report found that, while Class II recalls remain the most frequent mode of failing regulatory requirements, there has been a rise in Class I recalls that points to an unfortunate trend in medical device manufacturing. As Class I recalls are those where the product is likely to cause the user harm, every measure must be taken in order to ensure products are manufactured correctly.

Not only is there a risk to health and safety, but there is also a risk to a company’s bottom line. The authors of the report cite another study that showed how a single recall can reduce a company’s stock value by 10%. There is also a negative impact on public perception that can have incalculable costs.

The authors found that for the last year of the study, 2018, most recalls were caused by software issues, mislabeling of the product, and quality issues. These are avoidable errors that can be solved with up-to-date training and proper quality systems testing in place. Our Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions course is taught through case study, clearly demonstrating how to adhere to the latest FDA standards to bring international products to the US market, and comply with all regulatory requirements. Our instructor will also give you additional information and tools to ensure your communications with the FDA are clear, effective and mutually beneficial.

Registration is limited, so visit the course page or call 1-610-648-7550 to reserve your place. Early Bird reduced pricing is available.
 

Source:

https://www.medtechintelligence.com/feature_article/trends-in-medical-device-recalls/