Although many do not believe this, the pre-marketing authorization process (510k) for a Class II medical device in the USA is less complicated and costly than in the European Union and several Latin American countries.
The 510k procedure is based on the demonstration of substantial equivalence between the medical device submitted for approval by the FDA, and at least one medical device with similar technical characteristics and the same intended use which is already present in the U.S market.
It is helpful to clarify that:
For the FDA a medical device can range from a hospital gown to an artificial heart; including operating room lamps, gauze, condoms, wheelchairs, dental implants, etc.., there are about 1700 devices; classified into 16 categories.
Medical devices are grouped into 3 classes: I, II and III;
Thus, in a coarse way, devices grouped in Class I are mostly exempt from pre-marketing authorization; while class II devices (with certain exceptions), are subject to 510K pre-market authorization.
This is usually the first question that comes to mind; and of course, the answer will depend on the product and its characteristics. For example, an implantable device of any kind must demonstrate its bio compatibility; an electronic and/or electrical device shall demonstrate its safety and accuracy; a device with software use must demonstrate the authenticity of data transmission; an implantable and external orthopaedic device must demonstrate its mechanical strength; that is, the requirement will depend on the specifics of the type of device we wish to submit to the FDA clearance process.
There’s a lot of common sense in all of this; but it must be backed up by evidence obtained under accepted and established international standards for each case. Again, the key is to ensure in a technical and reliable way that the device is safe and works according to its indications of use.
The FDA is governed by its own 21 CFR 820 quality system known as GMP (Good Manufacturing Practices), which bears many similarities to the latest version of ISO 13485-2016, and is relatively easy to adapt. Adopting this system will prepare you for the FDA’s subsequent audit, which will certainly take place once your submission is cleared, proceed with the company’s registration, and start marketing your devices in the North American market.
Compared to other important international regulatory systems, such as the European, one of the main differences is that the FDA assumes that the device manufacturer works under a quality assurance system. In other words, at the time of submission for a 510K, it is not necessary for the manufacturer to provide a certificate that proves or certifies the device’s compliance with ISO 13485 or 21 CFR 820 standards.
A quick and accurate look at how long your 510k application may take once it is received by the FDA for review.
You’ll be able to learn about the 510k app’s reduced rate program for small businesses.