Is your product a medical device?

by Sarah Koehler | Jun 20, 2022 | Audits, Blog, Classification, Compliance, Consulting Group, Documents, Engineering, FDA, Guidance, Human Factors, Inspections, Medical Devices, Pharmaceuticals, Product Development, QMS, Quality, Quality Systems, Regulatory, Requirements, Risk Management, Safety, Standardization, Standards, Tools, Validation, Verification

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act¹.

The intended use and indications for use of your product are the first steps to identifying if the product is considered a medical device. The intended use is the general purpose of the device (its function). The indication for use describes the condition that the device will treat, diagnose, prevent, mitigate, or cure¹. The indication for use includes the patient population that will utilize the device as well. After the intended use and indications for use are determined for the device, the determination of an appropriate product classification should be completed.

Analyzing if the product is a considered a regulated medical device, includes three methods proposed by the FDA and are as follows:

Search the product classification database
Search for similar devices
Search for similar devices by device listing¹

When searching for similar devices the marketing pathway for the product can also be identified. Most class 1 and some class 2 medical devices are exempt from FDA review before marketing the product. It is important to choose the correct marketing pathway for your device, it is also required that all regulations are followed for a smooth FDA approval process for your device.

If your product is determined to not be a medical device, it may be regulated by another center of the FDA. There are many FDA resources and guidance documents available to ensure your product is marketed and approved properly. If your company needs assistance with device determinations of your product, EMMA International is here to help. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.

¹FDA (December 2019) How to Determine if Your Product is a Medical Device, Retrieved on June 20 2022 from https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.