• Melita Ball

August 25, 2020 Blog Post

Understanding Medical Device Recalls in the US

3 Tips for making the right decision

Today’s blog is all about a subject that most of us would prefer not to think about; however, it’s a topic that needs to be understood well before you need to perform it.  When you are faced with making the decision on whether or not to take actions in the field on a product that is not performing the way it should, it is never easy.  The tips below can help you navigate through the decision-making process using data as your guide to ensure not only the best outcome for your customers and your business but also to help you demonstrate to regulators that you used sound judgement based on facts to make your decision.

Before I get to the tips that will help you make the right decision, I’ll start with the framework for what counts as a recall in the United States regardless of the various terms typically associated with it. Many companies use terms like “Field Action” or “Correction” or “Service Notification” to describe actions that are intended to remedy a serious problem with the device or lot of devices that have already been distributed to customers. 

All too often, clients come to me and say, “Oh, this is not a recall, it’s a field action.”  The truth of the matter is that most all “Field Actions,” “Corrections,” and “Removals” meet the definition of what is meant by a recall. The FDA tries to make this perfectly clear by using words like Corrections and Removals instead of the word recall in the title of 21 CFR Part 806.  They also provide the following definition in their Enforcement Policy related to recalls (21 CFR Part 7). 

In order to fully understand what this means, we need to understand what is being referred to when it says “violation of the laws it administers and against which the agency will initiate legal action.”  There are two primary groups of violations that the FDA considers for taking legal action against a company. Adulterated Product A product is considered “adulterated” when the FDA finds that “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulation found in 21 CFR Part 820. Misbranded Product A product is considered “misbranded” when the FDA finds that “the product has been labeled or marketed in a misleading or fraudulent way” If the problem with your product is a result of any serious violations of the core regulations governing medical devices (21 CFR Part 820), then you will likely need to take actions that will be considered a recall.  Adulterated Product can be the result of things like … Design issues caused by missing or inadequate design reviews before transferring the product to manufacturing.

  • Manufacturing issues caused by lack of or inadequate process validation or inspections or testing of product before release.

  • Incremental changes to the manufacturing processes without adequate impact assessments, verifications, and validations before implementing the changes.

  • Contract manufacturing issues caused by lack of qualification or monitoring of contract manufactures.

If the problem with your product is a result of serious issues with the labeling or with marketing claims you’re making to sell the product, you will likely need to take actions that will be considered a recall. Misbranded Product can be the result of things like …

  • Marketing your device without the correct Clearance or Approval from the FDA.

  • Mislabeling of product including errors of identification, storage conditions, or shelf life.Marketing your device for something other than what it is Cleared or Approved for from the FDA.

  • Errors in the Instructions for Use that could cause patient or user harm.

Once the recall decision is made, you now have to determine the classification of the recall. 

This is vitally important because the documentation and actions are more or less cumbersome depending on the recall classification.  Alternately, you always have the option of reaching out to the FDA and have them make the classification determination for you.  The three recall classifications are: Class I - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Class II - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. Now that we have the general framework established and have defined what recalls are and outlined the various decisions you’ll need to make, let’s get to the tips that will help steer you through the whole process. Tip #1: Always start with a Health Hazard Evaluation (HHE). Spending time properly completing an HHE not only provides you with reliable information that will help you determine (a) if you need to perform a recall, and (b) the correct classification of the recall but it will also help you demonstrate to regulators your decision-making process and rationale for your decision. If you’ve never performed a Health Hazard Evaluation before, go <<HERE>>to get our complimentary HHE form and <<HERE>> to get the Guideline. Tip #2: Document a formal recall strategy. Going into a recall without a clear strategy for conducting the recall will likely be fraught with problems. A well thought out strategy will ensure that you will have everything you need to demonstrate the recall was completed effectively and provide the best possible experience for your customers. The strategy should include the following:

  • What needs to be done (based on the results of the HHE and the scope & depth of the problem).

  • Determination of whether a public warning is needed.

  • Who will do what, including what consignees will be required to do (based on how obvious the problem is).

  • How the recall will be issued and how consignees will be notified.

  • Determination of whether effectiveness checks are needed and; if yes, the level of effectiveness checks needed for closure.

  • Documentation needed for closure.

Tip #3: Create a Field Notice Letter template and a Field Notice Customer Response Letter template to reduce the amount of time spent writing these each time and to provide a consistent approach to recalls for your company. If you don’t already have these templates, click <<HERE>> to get our complimentary Field Notice Letter Template and our Field Notice Customer Response Letter Template.

As always, thanks for reading!  Stay safe and be well! Thoughts? Please comment below … Cheers! Melita Ball CEO and Principal Consultant

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