Navigating FDA Classifications: A Guide to Cleanroom Requirements for Medical Devices
In our last blog, A Guide to ISO Cleanroom Classifications for Medical Device Manufacturing, we explored the various ISO Cleanroom Classifications and the different types of components produced in each environment. Grasping these ISO classifications is a crucial initial step. Equally important is assessing whether your custom die-cut product needs FDA registration. If it does, it's essential to familiarize yourself with the three FDA classifications and their implications for your project.
Read on to learn more.
Intention. Indication. Risk.
Before we get into the different FDA classifications, however, it’s important to understand what determines which products fall into each of these categories.
According to the FDA, device classification depends on
- The Intended use of the device
- Indications for use
- Level of Risk
The FDA provides two main resources to help you navigate these determining factors. The first is the Device Classification Panel, which breaks down different types of medical devices into 16 panels to help determine your product’s classification. The second is the Product Classification Database, which allows you to search for your specific device’s product code.
We’ve included a high-level overview here, but we highly recommend reading these documents should you require more detailed information.
Intended Use
Where will your part be used, and how high is the risk of contamination?
Your product’s intended use has major implications on the FDA class it’s assigned. If the product is intended for use in a sensitive area of the body such as the bloodstream, it falls under a more stringent classification like Class III. Conversely, if the intended use of the product does not pose as much bodily risk, it would fall under less stringent classifications like Class I or II.
Advertised/Indicated Use
How will your product be marketed, and how will these claims affect your production requirements?
The claims that are made in your product’s marketing also have direct effects on your product's classification. Advertising claims such as the product's efficacy, cleanliness, alternative uses, or technological characteristics, all contribute to determining the proper FDA classification. It’s important to have a clear understanding of the claims you are making with your product so that you can best determine which classification it falls under.
“For example, a scalpel's intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device's labeling such as, 'for making incisions in the cornea'. Indications for use can be found in the device's labeling but may also be conveyed orally during the sale of the product.” (Classify Your Medical Device | FDA)
Cost vs. Risk
Is the risk of contamination worth the cost of manufacturing?
Since Cleanroom manufacturing is typically more expensive and only increases for each ISO level, it’s important to make sure your part meets the necessary contamination requirements without incurring unnecessary costs. This is why determining the right cleanroom manufacturing environment is so important, because selecting the wrong one may lead to unnecessary production costs as well as posing a risk to your customers.
Device Classifications
As laid out by the FDA, medical products fall into three distinct categories, (Classes I-III) based on the level of risk the device poses to the patient.
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CLASS 1 |
Class 1 applications include parts that don’t come into direct contact with vital parts of a patient’s body. These may include medical packaging or stick-to-skin wearable adhesives like pulse oximetry tapes. Because these products have minimal contact with the patient, the level of contamination risk is much lower.
ISO 8-9 cleanrooms are adequate for these lower-risk products. |
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CLASS 2 |
Class 2 applications include parts that come into contact with areas that have a higher risk of contamination. These parts enter places like the blood stream, which have a much higher risk of contamination. Examples include products like catheters and stents, which require a higher level of cleanliness than products that do not enter the body.
Products like these are typically manufactured in ISO 6-7 cleanrooms. |
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CLASS 3 |
Class 3 applications are utilized for products that are considered “life-sustaining”. These products enter vital parts of the body, like the heart or the brain, and require very high levels of cleanliness. The risk of contamination must be controlled tightly for products such as pacemakers, heart valves, and brain implants.
These products require the high sterility of ISO 5 and 6 cleanrooms. |
Helpful Resources
The idea of navigating these various rules and regulations can seem daunting. Thankfully, there are many helpful resources available to decipher these FDA standards and regulations, like the ones listed below:
The Value a Specialized Converter Can Offer
Taking the time to make sure you understand the important determining factors in the beginning stages of product development is a valuable investment that can help you avoid future roadblocks and costly mistakes, much like working with a trusted converting partner.
Enlisting the help of a specialized converter like JBC Technologies early on in your products' lifecycle, allows you to tap into our vast engineering expertise and industry connections with best-in-class material suppliers to take your medical device from prototyping to high-volume production. JBC is home to four cleanrooms across each of our facilities capable of meeting ISO 7-9 cleanliness standards. With a wide range of precision die-cutting capabilities at your disposal, JBC can take your medical device project well past the finish line.
Contact us today to get started on your next project.