What does ‘FDA cleared’ mean?
A medical device is FDA cleared for an indication. This is also referred to as a 510k Submission or PMA Submission and allows the device manufacturer to make specific claims that inform the general public of what the product can provide in terms of a treatment outcome. In the 510k Submission, the device must prove that it is substantially equivalent to a predicate device (an existing cleared technology) and the manufacturer has to provide results of a clinical study to prove efficacy. Attaining a clearance also means the device has been fully tested by an independent testing facility to verify it meets multiple requirements as stipulated by the FDA, including electrical functionality and safety under temperature and humidity conditions plus numerous additional benchmarks. Medical devices are not simply classified as “FDA Approved” but must be cleared for a specific indication (see FDA Approved below) and “FDA Registered” does not mean the device has been cleared by the FDA (see FDA Registered below). An FDA Registered device manufacturer cannot make any claims about treatment outcomes without having an FDA Clearance for specific indications.
What does ‘FDA approved’ mean?
Drugs, devices that can cause serious harm and other similar products must be FDA approved in order to be sold as a remedy for illnesses or diseases, whether it is a prescription or over the counter item. Medical devices can be FDA Cleared, but are not simply labeled as “FDA Approved” in general without having a clearance for a specific indication. Any entity that claims a medical device is FDA Approved but cannot provide either their 510K Number (7-figure number, starting with “K” followed by 6 digits) or “P” Number (as in PMA and is similar to a K Number but begins with a “P”) is attempting to mislead the public.
What does FDA Registered mean?
A facility can be FDA Registered which means the company operating the facility has informed the FDA what type of products it produces. Registration of a facility does not require any testing, verification or validation of the company’s products by the FDA. Being registered does not allow the company to make claims of any type regarding their products, and if they are doing so, such actions are considered illegal and prosecutable under Federal law.
Why does it matter?
More and more tech companies are creating products that can perform tasks such as watching for patterns in your heart rhythm or checking other vital signs that, in the past, only professional healthcare devices could offer. We are going to see more consumer health tech devices in the coming years, and many will be FDA cleared. Only companies with FDA cleared or FDA approved products will be able to make claims and legally promote the treatment outcomes their item delivers. Any company that promotes their product for a specific treatment without an approval or clearance could be taken off the market by the FDA and forced out of business.
The Contour Light System is the only pad-based device that has an FDA clearance for circumferential reduction/inch loss