The 510(k) procedure is based on the demonstration of substantial equivalence between the medical device subject to FDA approval, and at least one medical device with the same indication for use and similar technical characteristics, which is already present in the US market. Demonstrating substantial equivalence means proving to the FDA that the device that you want to market is as safe and effective as the device that is already on the market; known as a “predicate device”.
It is useful to clarify that:
For the FDA, a medical device can be anything from a hospital gown to an artificial heart; going through operating room lamps, gauze, condoms, wheelchairs, dental implants, etc., etc., etc... There are approximately 1700; classified into 16 categories.
Medical devices are grouped into 3 classes: I II and III;
Thus, roughly speaking , the devices grouped in class I are mostly exempt from authorization prior to marketing; Class II, with certain exceptions, if they are subject to a 510K type pre-market authorization.
What I need?
This is usually the first question that comes to mind; and of course, the answer will depend on the product for which we want to obtain approval and its characteristics; For example, an implantable device of any type must demonstrate its biocompatibility; an electronic and/or electrical device, must demonstrate its safety and precision; a device using software, you must prove the authenticity of the data transmission; an orthopedic device, both implantable and external, must demonstrate its mechanical resistance; that is, the demonstration will depend on the particularities of the type of device that we wish to submit for FDA approval.
There is a lot of common sense in all of this; but it must be demonstrated through tests carried out under international standards accepted and established for each case. Again, what it is about is technically and reliably ensuring that the device is safe and works according to its instructions for use.
The FDA is governed by its own quality system 21 CFR 820 known as GMP (Good Manufacturing Practices), which has many similarities with the most recent version of ISO 13485-2016, and its adaptation is relatively simple. Adopting this system will allow you to successfully face the subsequent FDA audit, which will come once your application has been approved, you have proceeded with the registration of the company, and you are marketing your devices in the American market.
One of the main differences with the European system is that the FDA assumes that the device manufacturer has a quality assurance system. In other words, it is not a requirement that at the time of applying for a 510K the manufacturer demonstrates any certificate that accredits or certifies its compliance with the ISO 13485 or 21 CFR 820 standards.