FDA Cleared vs. FDA Approved

Updated: Jun 6

As medical device innovation accelerates, it is still important to ensure solutions are as effective and safe as they claim them to be. The Food and Drug Administration (FDA) is responsible for ensuring safety and efficacy when it comes to consumer products, such as medical devices, vaccines, drugs, and more. Before entering the growing medical device market it is important to be familiarized with the regulatory pathways placed by the FDA.

The FDA has three categories for medical devices: Class I, Class II, and Class III - each is distinguished by the potential risk to the consumer. The amount of risk the product may determine the type of requirements needed to legally sell your product.

Class I medical devices have minimal risks such as stethoscopes, band-aids, and corrective glasses. Class II medical devices have medium risk. Some examples are catheters, blood pressure cuffs, and pregnancy tests. Lastly, Class III medical devices impose the most risk, for instance, pacemakers, heart valves, and cochlear implants.

There are two regulatory pathways that can be taken to meet FDA requirements to get a medical device on the projects: FDA Clearance and FDA approval. FDA clearance requires a Premarket Notification (PMN), also known as a 510(k). In this application, you must provide enough evidence to show your product is similar to another legally marketed medical device. These comparisons should prove your device is as equally safe to use and effective as the legally marketed device. The 510(k) route is faster and more cost-effective than the second pathway which is to seek FDA approval through a Premarket Approval Application (PMA). This second route requires clinical testing and sufficient scientific evidence to show the effectiveness of the device and its safety in humans. PMA is required for medical devices proposing a different function, purpose, and design than existing products on the market.

Getting FDA approval is lengthy, costly, and resource-intensive for a company to achieve. FDA clearance provides a more accessible route to the medical device market for Class I and Class II devices. These devices pose minimal risks which can be exempted altogether. Meanwhile, all Class III medical devices are required to go through FDA approval.

To navigate FDA regulations in the medical device market and learn more about Premarket Notification (510k), Investigational Devices Exemption (IDE), and Premarket Approval (PMA), sign up for our content-rich FDA Online Course.

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