The Nemedio Blog:  Demystifying Compliance

your guide to product development and compliance for medical technology

My product is Class I, do I still need a Quality System?

April 21, 2022

FDA classifies medical devices according to the level of control necessary to assure their safety and effectiveness. There are 3 classes of medical device, with Class I requiring minimal controls and Class III requiring the highest level of control. 

If you know you’re a Class I product, Congrats! You have much fewer compliance stuff you’ll need to do…since your product is designated as low risk, you are likely exempt from premarket notification requirements (meaning you don’t have to submit anything to the FDA to sell the product).

*However* most Class I and Class II devices are still required to comply with good manufacturing practices (GMP) and the quality system regulations (as specified under 21 CFR Part 820). 

To determine if your product is required to comply with these requirements, you need to determine if your device falls under an existing FDA product code. From there you can figure out how complicated of a quality system you need to set up. Even devices that are exempt from the QS regulations are still required to comply with “general controls” - these are the controls required for all products under the FDA’s jurisdiction, and includes things like complaint handling and record keeping. 

Need some help identifying your product code and figuring out if you need a quality system or how “big” of a quality system to set up? 

Schedule a free consultation using the calendar link below to get your questions answered.


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