Which Medical Device Classification Makes Sense For Your Clients?

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
• Bandages
• 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
• Syringes
• 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
• Pacemakers
• Defibrillators
• Cochlear implants
• Fetal blood sampling tools
• Implanted orthopedic prosthetics
• High-frequency ventilators
• And more