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FDA Warning Letter Trends Show That Medical Device Companies Need To Improve These 3 Things

U.S.-based Medical Device companies, take note: Between October 1 and December 23, 2014, the FDA issued 11 FDA Warning Letters to your peers. With an average of almost one per week, it’s clear that medical device companies are BIG on the FDA’s radar right now.

While the Letters touch on nearly every aspect of the quality management system (QMS), there are some clear trends across all of the Letters:

  • Medical Device Reporting (MDR): Four recipients of Letters were in violation of the FDA’s MDR requirements, governed by 21 CFR target_shutterstock_142754806 small803.17. My favorite quote related to MDR violations comes from a Letter issued on November 5, 2014, in which the FDA wrote: “Specifically, your firm does not have any written MDR procedures.”
  • Complaint Handling: Eight recipients of Letters were in violation of the FDA’s product complaint handling requirements, governed by 21 CFR 820.198. In a Letter issued on October 10, 2014, the FDA wrote this little gem about not adhering to existing complaint handling procedures: “A complaint that you became aware of on 4/21/14, involving an “ignition” event on a medical gas pressure regulator that you contract manufacture, was not entered into your complaint system until 7/25/14 during the current FDA inspection.” What can we learn from this company’s mistake? Always follow your own written procedures – not just when the FDA is onsite. And, remember that electronic records have date and time stamps, as well as audit trails.

  • Corrective and Preventive Actions (CAPAs): Nine recipients of Letters were in violation of the FDA’s CAPA requirements, governed by 21 CFR 820.100. In a Letter issued on December 8, 2014, the FDA gave this example of CAPA procedures falling short: “CAPA #1010 was opened on August 28, 2013 to address complaints with cleaning brushes not being able to fit properly into the working channel of endoscopes. The root cause investigation noted that the {name blinded}cleaning brush is not included with the Flex-X2 Ureteroscope, model # #11278AU1. This CAPA was closed on September 12, 2013 without ensuring the appropriate brush is referenced properly in the future for all affected models.” This mistake specifically violates the 21 CFR 820.100(a)(4) requirement, which calls for making sure that a corrective action is both effective and does not adversely affect the device. It’s not particularly effective to simply note in your internal files that the proper cleaning brush isn’t mentioned in the literature that comes with the device.

Considering the FDA’s focus on medical devices and the consistency with which the three areas above are cited for violations, now is the time for medical device companies to seriously consider a compliance assessment of their QMS, as well as the implementation of one or more IT systems to help facilitate these processes. This should be a top priority in Q1 of 2015 – before the FDA comes a-knocking.

For a compliance assessment or a requirements workshop to help identify the right IT solution(s) for your organization, contact us. In the meantime, here is an example of one medical device company’s “preventive action” to avoid an FDA Warning Letter.


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Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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