Hi Esteban,
Thank you for your questions. There is a lot to cover in such a simple remark!
People generally have very little understanding about the FDA's (and the regulatory bodies of other countries) role in ensuring people get safe and effective medical treatment. The FDA is a very large organization and you can be certain that they truly are ensuring that medical devices and drugs are both safe
and effective.
In the way you have presented it, I believe you have been looking at equivalence in terms of device code. Yes, the FDA groups devices into categories based on similar characteristics that devices might have. That does not mean though that all devices assigned a given code are identical. That is far from correct. Consider, for example, IV bags. There are big ones and small ones, some made from different materials based on what they might contain, they must protect and preserve and not adversely affect the contents they hold, some can be frozen, some not, still they are grouped under common codes. This coding system is just the most superficial level of classification. Generally, it does group products with similar characteristics because it allows some general rules to be applied to the group that make sense - mostly regarding safety. Two devices sharing a common device code does
not mean that the products are the same. The device code does though mean that there is a certain minimum set of criteria that every device of that code must meet but in no way does it mean the devices are universally interchangeable. The regulators have to start somewhere and this is the beginning.
"FDA registration is no guarantee of efficacy" - this can be very true or very false. Sadly, the general public has been misled by too many companies selling "snake oil" / sham products that it has undermined the credibility of what the FDA stands for. Companies making homeopathic remedies that are consumed need only need to demonstrate that they are safe for consumption as a food to get labeled FDA Registered as a food. Nefariously, they then go out and tout medical benefits only to end their ad with a disclaimer that the product "does not heal, treat, or prevent any disease". This undermines the integrity of the FDA so much it is truly a disservice to the public. People don't realize that when you get to real pharmaceuticals and medical devices, that same organization (FDA) goes to great extents to ensure the well-being of the public is protected. Depending on the Class of a medical device (Class I, II, III, or IV) different levels of vetting are performed.
Safety is always the overriding priority for FDA. First and foremost, an FDA registered device must be as safe as possible and the company must demonstrate that ongoing monitoring and improvement of safety related items are given proper attention. People don't realize that many braces and supports and cold packs (including most sold in pharmacies) are not FDA registered medical devices but are really sold as athletic apparel. FDA registered medical devices of this sort are typically of the lowest class (Class I) but that still means there are safety concerns that must be addressed that the athletic devices do not, and it also means that the device and the manufacturer are subject to FDA scrutiny.
Consider the fabric. There are standards of safety that must be met for materials that are used in the manufacture of baby clothes – these are the toughest apparel standards and there is a whole list of known dangerous substances that the material cannot contain because babies are known to suck on their clothes. There is another standard for adult undergarments that is slightly less restrictive but still tight because they are in constant contact with your body. There is another standard that is less restrictive yet for pants and shirts because they are not in contact with your body as much as under garments. There is yet a lesser standard for coats and apparel that are really isolated by other layers of clothing, and then there is sports equipment that is unregulated. You would be shocked at how many braces are classified as sporting equipment (ie no regulation on the materials used even though people fasten them right to their skin). Even scarier is athletic tape which people adhere to their skin and wear for hours while they sweat. As soon as you get to an FDA registered medical device, there is instantly a legal obligation for the company to make the device safe for the application even at the minimum level.
At King Brand we don’t just meet the minimum level of material safety. For our products it would be reasonable to submit to the FDA that material suitable for undergarments is suitable for our products. We’re safer than that. We’re safer than baby clothes too. King Brand uses material rated ISO 10993. This means that the material isn’t just free of known dangerous substances, but that the material has gone through extensive testing on living tissue to guarantee that it has no toxic or other adverse impact on tissue health. There’s a big difference between just avoiding certain chemicals and actually testing and proving that the material is safe. To be clear, baby rated material does not mean that it has passed ISO 10993, it means it just doesn’t contain the chemicals on the current ban list.
We are not required to use ISO-10993 materials in our products – that’s way beyond the requirements of our device classification – but we do use them because we have that commitment to the quality of our products and the well-being of our customers.
Our BFST devices are Class II medical devices that share a category with heating pads that are used as medical devices. Do we like being in that group? No, but unless we go through an arduous process and millions of dollars to have FDA set aside our own device category, it’s the best category for the starting point of FDA minimum standards for safety. In terms of beneficial use, we consider our device more akin to diathermic Ultrasound and Shortwave Diathermy, each of which have their own codes but we are sufficiently unique from those technologies that we don’t belong there. Eventually we will have the resources to pursue a unique code for our technology, but the big motivation for that is really to get unique HCPCS codes so that insurers will pay higher reimbursement values for our products (they go by the medical device codes too). Where efficacy and safety of our products are concerned, that really is the function of the FDA.
Let’s discuss our claims. You wrote, “To simply claim that the BFST wraps are superior to other products that might be therapeutic is not sufficient, in my view”. FDA does not share your view. In fact, the claims that any medical device manufacturer makes are very much a concern of FDA (and Health Canada and other countries’ health regulators). The claims of other products that share a device class don’t matter at all. The claims the manufacturer makes about what
their product does matters a whole lot. You can be certain that FDA looks very closely at the claims and then looks to see if you have evidence to back up your claims. The more significant the claims, the more closely they scrutinize how diligently the company has done their research. Now, to be clear, FDA does not review the data itself nor do they try to make conclusions from the research materials. What they do is examine whether due diligence has been done that it is reasonable for the company to make such claims. Don’t interpret this as the FDA doesn’t care. The FDA cares, but they simply don’t have the resources to review the data and make their own conclusions about every study for every device. Think about it, they’d need a specialist about every technology and they'd spend tons of time on every device! This is part of the reason you will see statements disclaiming FDA’s
responsibility for the claims.
FDA isn’t responsible for the claims, but you can be sure that they hold the manufacturer entirely responsible for the claims being made. To protect the public, they review that due diligence was done without actually pouring through the material. Then, on an ongoing basis, they enforce practices and policies that would expose any failure of a device to meet those claims. FDA strictly requires that companies record any alleged deficiency of a product or a products performance no matter how minor. When they come to inspect a facility (usually a very in-depth process of a week or longer) they go through and take back with them all the records of these complaints and very closely scrutinize what the company did about each one. If they saw evidence of failure to meet the claims they would be all over it. When it involves medical devices – what a company claims their device does is paramount. Your device has to fulfill the claims. Every device in the same device category does not make the same claims. What is claimed by a specific device is what is important – not the device code.
You are not the first person to express a desire that we expose more information about our technology. One reason is because we have no desire to tell other companies how to make our products. We’ve spent hundreds of thousands of dollars on R&D and we have no intention to give it away. Has FDA seen this information? Absolutely. The other reason is because it prevents other companies from producing sham products claiming they are the same because they have a common property. If we say this device uses 1 watt of power, someone else will say their product uses 2 watts of power ergo it must be better even though the power is doing something completely different. If someone wants to compete with us, they can do so based on what the products claim. And we can make our claims because our products do what they say they do. It’s as simple as that. FDA looks at our claims you can be sure of it. So does Health Canada and so do our ISO regulators.
The proof is in the pudding, Esteban. You’re welcome to give our products a try.
