For example, with a Point-of-Use Water Filter, a Class II medical device, if the product were to not perform as claimed and had been used according to the indications for use, liability would fall on the manufacturer.
This is because all medical benefit claims being made have also been scrutinized by expert reviewers and have been deemed safe and effective in the intended use.Ī FDA 510(k) cleared product also protects the user from liability. The user of a FDA 510(k) cleared product may be able to feel a certain comfort level with the product that they are using. It also prevents unsubstantiated (false) claims from appearing on labeling or advertising media. The FDA does not test the product themselves, but instead reviews the data that has been submitted. For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process or pre-market approval (PMA).Ī FDA 510(k) cleared medical device is allowed to make claims on the product that have been reviewed and cleared by the FDA. When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. There are important differences between “cleared” and “approved”. Before submitting a 510(k) application to the FDA, the medical device manufacturer must first determine which class of device their product belongs to. 2 Class III devices present the most risk during use and would include life supporting devices. For example, a Point-of-Use Water Filter is considered a Class II medical device because it presents a moderate amount is risk during use to the patient or care giver. There are 3 classes of medical device in the US: Class I, Class II, and Class III. 1 Once “pre-market clearance” is received from the FDA the device can be distributed commercially immediately.
To be substantially equivalent, the product must meet criteria for the same intended use, have the same technology or (slightly) different technology but produces similar end results, and be safe and effective. To do this, in most cases a company must compare their product to one already cleared by the FDA and provide evidence that their product is “substantially equivalent” to the previously cleared (legally marketed) device. Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. The content below pertains to FDA 510(k) Medical Device clearances and is intended for the United States.