What you Need to Know about FDA Device Regulation

Marketing Sunglasses, Bandages, Hospital Equipment, Pregnancy Test Kits, Cosmetic Devices, Personal Lubricants and More

The U.S. leads the world in medical innovation and is the largest consumer of medical devices in the world. We use medical devices daily, whether it is throwing on a pair of sunglasses, hitting the ski slopes with a pair of ski goggles, using a pregnancy test kit or powered wheelchair, or using beauty devices to improve the appearance of facial wrinkles and fine lines. But how do we know if a product is a medical device, and what are a company’s marketing requirements?

Responsible for assuring the safety and effectiveness of medical devices, the FDA regulates the marketing of medical devices in the U.S. based on the product’s FDA device classification and level of risk or harm to the user. Typical device marketing pathways include premarket notification (known as 510(k) clearance), premarket approval (PMA), Humanitarian Device Exemption (HDE) and De Novo pathway.

Class I devices generally present minimal potential for harm, and includes products like sunglasses, bandages and ski goggles. These types of medical devices must comply with general control requirements including device registration and listing, labeling and manufacturing compliance, and compliance with reporting requirements. As most Class I devices can be marketed in the U.S. without FDA clearance, Class I devices typically have the fastest route to market.

Class II devices present a moderate risk of use to a consumer, and generally require premarket notification (510(k)) clearance, meaning that the FDA must clear such devices prior to their marketing in the U.S.  Most medical devices fall into the Class II category. In this pathway, a device manufacturer must demonstrate to FDA’s satisfaction that the device is substantially equivalent (safe and effective) to a device already on the market. FDA 510(k) clearance typically takes anywhere from 3-9 months, and filing fees can vary depending on whether a company qualifies as a small business.

Class III devices generally involve higher-risk and novel devices that comprise of new materials or that differ in design from products that are already on the market, and for which device manufacturers must pursue Premarket Approval. This process usually involves 1-2+ years and is relatively more cost- and time intensive than the other marketing pathways.  

In determining a Company’s US device compliance requirements, it is important to first confirm that the product is a medical device, next to identify the FDA device classification, and then to determine the optimal regulatory pathway. If a medical device will be imported, it is also important to identify the appropriate FDA product code and Affirmation of Compliance codes to assist with smoother product entry.

Also, if you are marketing a product that is making some medical claims, but you are seeking to position the product as a non-medical device, there may be ways to defensibly position the product outside of FDA device regulation. Additionally, there are mechanisms to request FDA informal FDA guidance on a device’s regulation and marketing requirements. In all cases, it’s important to understand and comply with the required device compliance requirements to avoid FDA enforcement risk!

For further questions on device classification, regulatory pathways, 510(k) clearances, please email us at info@garg-law.com. For assistance with device registration and listing, please see here.