Doctors' tools are one type of medical device regulated by the FDA.
The U.S. Food and Drug Administration monitors medications, equipment and other medical devices to make sure they are safe and effective purpose. Companies wanting to sell devices first need approval from their federal agency.
The FDA says a business first needs to determine whether a product is a medical device or another type of medical product because that will determine what types of regulations it is subjected to. Some medical devices, such as those that emit radiation, have additional regulations. The FDA groups devices in Class I, II or III to determine how stringent of regulations apply.
Registering and Listing
Before companies can legally market and sell medical devices, they first need to begin the FDA approval process by registering with the agency and formally listing the products. Companies need to pay registration fees and provide the devices' names and intended uses. Foreign companies wanting to sell in the U.S. need to have a U.S. agent to handle arrangements between the business and FDA.
Class I and II Devices
Certain medical devices don't need the FDA's approval before going to market. Companies that want to bypass the approval process must first fill out a 510(k) form. The forms, as established in Section 510(k) of the Federal Food, Drug and Cosmetics Act, mandates that businesses must first prove the devices they want to sell are safe and do what they are supposed to. Business also need to demonstrate that their products are similar enough to other already FDA-approved products on the market. The FDA classifies devices with 510(k) as Class I or II.
Class III Devices
The FDA classifies devices that can have serious risks when used as Class III, meaning they must go through a more stringent review. Companies wanting to sell Class III devices must provide data proving they are safe and effective.
Business can use Class III devices before receiving FDA approval during clinical studies. To receive the exemption, the products cannot be a serious risk to anyone, and anyone who uses it must first give consent with the understanding the device has not yet received FDA approval.
Quality Systems
After the FDA approves medical devices for sale in the U.S. and companies begin manufacturing them, the companies need to establish ways to monitor the quality of their products. The FDA does not have specific guidelines for medical device production. Instead, it uses the same broad quality system guidelines it sets for other products, such as food.
The FDA says manufacturers should use "good judgment" when setting up quality systems to make sure it is effectively producing the medical device and guaranteeing it is safe for use.
Reports
Companies need to report to the FDA if they receive complaints of a device having adverse affects. Businesses have up to 30 days to report to the FDA if a device they sell malfunctions or causes injury or death. If a product needs immediate action, such as a recall, the company has five days to report. The FDA might also require a company to provide annual reports for certain products.
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