Engineering Expert Witness Blog

     When I was a kid in Chicago back in the 1960s there was a show on television called Bozo’s Circus.  Lucky kids were picked from the audience to play a bucket game.  There were six buckets in a row, as I remember, each about a foot from the last. The kids had to stand in front of the first bucket to play. By the time the kids got to throw their ball into Bucket No. 6 there was probably ten feet for the ball to travel.  So what would happen if the ball didn’t sink into the desired bucket, which would happen more often than not it seemed?  Then Ringmaster Ned would direct Cookie the Clown to chase down the rogue balls.

     So what does this have to do with the FDA and medical devices?  Well, in the loosest of terms you may think of the FDA’s classification system as Buckets 1 through 6 and Ringmaster Ned as the regulatory agent of the game.  Okay, I’m really stretching on this analogy, but I did want to introduce some levity into the discussion!

     Last week we discussed the fact that the FDA classifies medical devices into three main categories, Classes I, II and III, Class I devices posing the least risk to patients, Class III the most.  Now we’ll see how the FDA regulatory control system functions to oversee the medical devices within each classification.  To begin with, you should be aware that regulatory controls are themselves divided into General and Special Control categories.  In this article we’ll focus on General Controls.

     General Controls can apply to medical devices within all three FDA risk classifications.  They include requirements for:

— Registering of medical device manufacturers, distributors, repackagers, and relabelers with the FDA.  This registration basically lets the FDA know they exist as an entity, and it gives the Agency information about who to contact should the need arise.

— Listing medical devices with the FDA so the Agency can keep track of what kind of devices are being marketed in the United States.

— Manufacturing devices in accordance with FDA Good Manufacturing Practices (GMP).  GMP regulations require a quality approach to manufacturing, an approach which is designed to minimize or eliminate instances of contamination, defect, and error which could contribute to harm or kill a patient.  GMP regulations address issues like sanitation, quality control, complaint handling, and record keeping.  Effective complaint handling and record keeping systems are key in identifying and resolving issues that may pose increased risk to patients.

— Labeling devices.  The FDA requires that medical device labeling provide explicit directions for use.  The labels must also contain appropriate warnings as needed to ensure the safe and effective use of the device.

— Submitting a Premarket Notification to the FDA for approval before marketing a device, also referred to as a 510(k) within the industry.  This name comes from the section of the federal regulation that deals with it, that is to say, companies must submit 510(k) documents to the FDA to demonstrate that the device they wish to market is comparably safe and effective as other equivalent devices already on the market.  A 510(k) can only be submitted if Premarket Approval (PMA) for the device is not required.   We’ll talk more about this in a future article on Special Controls.

     Now, because they pose such a low level of risk, many Class I medical devices are exempt from the requirement for 510(k) submissions altogether, and they may even be exempt from compliance with GMP regulations.

     In a nutshell, General Controls help the FDA keep track of what products are being sold by whom, and how effective and safe those products are.  It also provides guidelines to medical device companies to help ensure their introduction of safe and effective products to the public. 

     So what happens when a device falls outside of the parameters of the General Controls watch?   That’s when more stringent guidelines come into play, for it has now entered the realm of Special Controls.

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