How to Classify Your Medical Device for the FDA

Posted by Lisa Capote | Mar 09, 2017 | 0 Comments

When you have a medical device to register with the FDA, the first step is to classify the device. The device's classification will help identify the it within the FDA and determine the device's level of risk. By understanding how to classify your medical device, you can ensure your device is properly registered and ready to market.

Class I

Many Class I medical devices aren't what a lot of people would consider medical devices. A motor-less toothbrush or a callus remover could be considered a Class I device. These devices are subject to the least strict FDA controls. General controls require a mandatory recall if the device is found to be defective, among other controls.

Class II

Examples of class II medical devices might be a motorized wheelchair or an over the counter blood pressure monitor. Class II devices are subject to special controls, as well as all general controls. Special controls would require certain guidelines and performance standards, as well as special labeling requirements on how to use the product safely and effectively.

Class III

A Class III medical device is the highest class device and applies to devices like medical implants. Class III medical devices are subject to general controls and must have premarket approval by the FDA before market placement and use by hospitals or doctors. This class is the most involved and requires a great deal of work back and forth with the FDA.

When to Contact an FDA Medical Device Lawyer

Any time you are manufacturing a medical device, it's important to consult with a lawyer regarding classification and registration. Therefore, to ensure your device is approved for market, make sure you have everything in order for the FDA.

Many companies and entrepreneurs are intimidated by the requirements of the FDA, whether they face general controls, general controls and special controls, or general controls and premarket approval. At the Capote Law Firm, we can help you navigate the challenges set forth by the FDA. Ultimately, this can help you get your medical device on the market, so you can grow your business.

Call today for a consultation to discuss your legal options at (786) 871-5680.

About the Author

Lisa Capote

Ms. Capote is the founder and Managing Partner of Capote Law Firm. She founded the minority, woman owned law firm in 2006 with the goal to provide quality service to FDA regulated companies. Since that time her practice has grown to include other US federal agencies as well as an international trade component.


There are no comments for this post. Be the first and Add your Comment below.

Leave a Comment


AV Preeminent Rating

10.0Lisa Capote


Lisa Capote
Rated by Super Lawyers

loading ...

Copyright © 2021 Capote Law Firm

This website is intended solely to convey general information about Capote Law Firm and should not be construed as legal advice. Neither your use of this site nor your transmission of electronic mail to Capote Law Firm or any of its lawyers will create an attorney-client relationship. The formation of an attorney-client relationship requires satisfaction of multiple factors such as resolution of possible conflicts of interest, an appropriate fee arrangement, and mutual agreement on the terms of the engagement. This Website should not be interpreted as an offer by Capote Law Firm or any of its attorneys to practice law in any jurisdiction in which Capote Law Firm or the attorneys are not properly authorized to do so. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you free written information about our qualifications and experience or call us to discuss any specific questions.