Steven K Baker

Cleared or Listed – economies of truth

February 25, 2016, by StevenKBaker, category Blog

October 29th

I recently presented at the National Estheticians Teacher Training on Light Emitting Diode Technology that was held prior to the International Congress of Esthetics and Spa in Philadelphia over the weekend of October 24th and 25th. I took the opportunity to attend the exhibition on the opening day (25th) and noticed that there were some companies present at the show that were selling devices that clearly did not have the correct regulatory endorsements. In light of this I thought it might be a good idea to clarify the differences between FDA listed, cleared and approved medical devices and also those devices that are exempt.

The FDA define a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

First let’s deal with devices that are exempt. Not all devices need to go through the rigors of FDA and these devices are called exempt and are classified by the FDA as low risk or class I. It is not to say that manufacturers of class I devices are not controlled in anyway and they still must meet certain controls and criteria that cover packaging, labelling and assurances that the device is manufactured under a recognized international quality standard.  Examples of a class I device would be a microdermabrasion machine, used to remove the dead layers of skin by an esthetician.

Class II and III medical devices will go through a 510k process to “clearance” or a premarket approval (PMA) to “approval” respectively. The difference in the “terminology” is important because the routes to market authorization differ in how rigorous the review is in terms of safety controls that are expected of the devices. Examples of class II devices would be LED devices for the treatment of wrinkles and acne and Intense pulsed light systems for hair removal. Class III devices include replacement heart valves and silicone breast implants.

In esthetics and esthetic medicine, most devices will belong to class II and will be approved by the 510k route or the recently adopted De Novo route. If that is the case a manufacturer should be able to reference their “K” number (a reference number given to each submission that is handled by the FDA). You can then check the K number using the FDA website. By typing the K number into the FDA search engine at a summary page will appear that gives you information on the manufacturer and the device. Towards the bottom you will see a link to “Summary” by clicking this you’ll get to see a concise report including what data the manufacturer submitted and what international standards the device complies to. You’ll also be able to see what the device’s indication for use is or what it is “cleared for”. The indication for use should match the marketing claims that the manufacturer is claiming for its device. Be aware that manufacturers will sometimes say that their device is FDA cleared and not be specific when it comes to what indications it can treat, checking the FDA database will give you assurances of the legitimacy of the claims.

Often manufacturers state that their devices are “listed” or “registered” with the FDA, this really only means that the company has completed a simple on line registration form, it does not mean that the device can be legally sold for that indication that it is claiming use for. If a device has a medical indication for use, let’s say for the treatment of acne vulgaris, then it should have undergone some sort of validation by the FDA for safety and efficacy, either a 510k or PMA. Listing or registration is NOT such a validation process.

So, what do you think ?