Finding devices that fit the needs of your clients is easier than ever when you collaborate with an experienced, multi-faceted manufacturer. FDA medical device classification is a crucial first step in commercializing a new device, and Remington Medical can help you find the instruments and tools that are right for you (and meet all relevant industry standards).
FDA Medical Device Regulations: What You Need to Know
Every single medical device that’s ultimately marketed (not necessarily manufactured) in the United States is ultimately grouped into three broad, distinct classes: Class I, II, or III. For a lot of casual consumers and manufacturers, the guidelines can be confusing—if you’re not familiar with how the devices are made or the nuances of the classification system, there’s a lot you need to learn before you make a purchasing decision. Fortunately for our customers, Remington Medical manufactures a diverse range of instruments that meet all applicable medical device manufacturing regulations.
In this blog, we’ll talk about the characteristics that set apart each classification category, and how each device might theoretically fit with your healthcare clients’ needs.
What Are the Three Different Classifications?
While many manufacturers are already acutely aware of the different FDA medical device classifications and what sort of products and devices they’re looking for, it’s worth going over them again just so there’s less margin for error. The classifications are:
Class I Medical Devices
Class I devices are the most common classification, constituting over 47% of approved devices on the market today. These devices present the least amount of risk to patients and device users, and therefore, they’re subject to the fewest regulatory requirements. FDA Class I medical device classification covers a wide variety of devices, including:
- Tongue depressors
- Oxygen masks
- Reusable surgical scalpels
- Hospital beds
- Electric toothbrushes
- And more
Remington Medical develops a number of Class I devices with quick, predictable turnarounds so that our clients can meet their healthcare partners’ needs and receive low-cost, affordable treatment. Class I devices are faster to market than Class II and Class III devices—they offer minimal risk for patients and are almost never essential for treating patients in life-threatening circumstances. While not exempt from FDA general controls, many are exempt from certain FDA requirements, like 510(k) (premarket notification) and PMA (premarket approval).
Class II Medical Devices
This is where things start to become a little more complex. Class II medical devices offer more complications than Class I because of the increased risk they pose for patients or device users; they’re often under more scrutiny and subject to closer evaluations and stricter standards for design, manufacturing, testing, and labeling. Class II devices are more likely to be used in life-saving procedures, so there’s really no margin for error when it comes to quality and performance. Marketing of Class II devices in the US is subject to clearance under FDA’s pre-market notification (510(k)) process, though certain Class II devices may be exempt. Examples of Class II medical devices include:
- Intravascular Catheters
- Pregnancy test kits
- Blood transfusion kits
- Contact lenses
- Surgical sutures
- Blood pressure cuffs
- And more
Controls vary depending on the device, but they can include the following standards:
- FDA Guidance documents
- Patient registries
- Postmarket surveillance
- Device performance standards
- Premarket data requirements
At Remington Medical, we manufacture devices that meet or exceed all Class I and II manufacturing standards, giving our customers the confidence they need to stand behind our products when working with a third-party healthcare provider.
Class III Medical Devices
Class III devices make up the smallest portion of devices, with only 10% falling into this classification category. Class III includes many complex, high-tech instruments like smart medical tools, life support systems, and other invasive and higher risk devices. This is the class typically required to undergo the most strict of assessments and evaluations. Marketing of Class III devices in the US is subject to FDA’s Pre-Market Approval process. Examples of Class III medical devices include:
- Breast implants
- Cochlear implants
- Fetal blood sampling tools
- Implanted orthopedic prosthetics
- High-frequency ventilators
- And more
Find What Works For Your Clients
At Remington Medical, we’re committed to finding dynamic, unique ways to help your clients provide superior care for their patients. With award-winning manufacturing services and reliable production timelines, you can rest easy knowing that you’re working with one of the best in the business when you choose Remington. For more information, reach out to our team today.
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