Taking a Device to the US Market: The Hunt for a Predicate

Our UK and European Clients often ask us what the route is to achieve regulatory compliance for their device. Of course, it’s an area of great interest; the US being such a potentially lucrative market. Happily, IMed can support clients entering the US, as we can with most global markets. But with the current fight for notified bodies this side of the pond – the capacity and efficiency of the US FDA system is becoming more attractive to manufacturers of new devices, who feel it will be a quicker route to sales. So, here’s my preliminary run down of what’s different about the regulatory approach in the US:

510(k) or De Novo Submission?

The creation of a premarket submission is the main mechanism by which a medical device manufacturer can achieve clearance, approval, or grants from the FDA in order to legally put their device on the market within the US. The route of premarket submission that a manufacturer can take is governed mainly by device classification, associated risk, and the extent to which the category of device under evaluation can be said to be “well-established”. The 510(k) submission route and the de novo pathway are the two main routes by which a manufacturer can achieve a premarket submission, and subsequently be able to sell a medical device within the USA.

The 510(k) Route: Picking a Predicate

The 510(k) submission route, also known as the premarket notification, is the pathway that the majority of medical device manufacturers use. The principle in which this submission route works, is through the identification of a comparable device, that currently exists in the US market, and using this device, known as a predicate device, to demonstrate your device can perform at least as effectively and safely. This is known as demonstrating your device to be ‘substantially equivalent’ and requires the devices to have the same Intended Use. One highly recommended method by which potential predicate devices can be identified is through identifying FDA product codes applicable to your device, and identifying cleared devices with the same intended use which also use the same product code. To demonstrate ‘Substantial Equivalence’, the FDA typically allows an extensive comparison of the two different devices’ specifications, their intended use, and further comparisons of all other relevant device characteristics. Clinical performance testing is, in general, mostly not required for 510(k) submissions, although it may be requested in certain instances, and particularly if non-clinical testing methods are deemed insufficient.

Who is Eligible for the 510(k) Route of Submission?

Not all devices are expected to conduct a 510(k) submission; for example, many Class I devices do not need to obtain 510(k) clearance and instead only have to adhere to general FDA controls. The requirements and type of documentation needed when producing a 510(k) submission may differ depending on whether the device under evaluation meets certain criteria, and if so, a manufacturer may be eligible to provide an abbreviated or a special 510(k) submission rather than a traditional one. It should also be noted that the 510(k) route of submission will rarely be an option for manufacturers of Class III and some Class II devices, as the FDA requires these devices to be assessed through a more stringent submission process, called the Premarket Approval (PMA).

Manufacturers who have already successfully completed the FDA approval process via a 510(k) submission, may also be required to produce a new submission. This can occur if the device in question is subject to significant device modification, design alterations, or changes of the intended use or indications.

De Novo: What to do if you can’t Find a Predicate

The de novo pathway to premarket submission was designed as a route for novel devices with a low to moderate level of associated risk and that were unable to demonstrate ‘substantial equivalence’ to a predicate device. To be eligible for the de novo route to market, a device has to meet the FDA precedent of what is deemed as a new category of device. Eligibility is also dependent on the level of associated risk with a device and the ability to recognise and mitigate those risks. The FDA describes the de novo pathway as a way in which devices that would usually be classified as Class III, due to them not previously fitting into any of the lesser classifications as a result of their novelty, can be classified as Class I or as Class II. The de novo pathway can also be forced upon a manufacturer, should they be unsuccessful in claiming Substantial Equivalence to the comparator device used in the 510(k) submission.

When a novel device manufacturer successfully goes down the de novo pathway, the FDA determines the classification of that device and also provide regulations, necessary controls, special controls, and a FDA product code. This also means that the device becomes eligible as a predicate device for any future 510(k) submissions.  Another consideration for manufacturers going down the de novo pathway is the level of both general and clinical evidence required to demonstrate that the device is performing as it should, and that it meets safety expectations. This level of evidence will usually therefore need to be more extensive for the de novo route, than for those using the 510(k) submission route.

Never fear… IMed are here!

So, as you can see – the FDA’s approach to Regulation is quite different to what we encounter in other markets. But IMed’s team of expert consultants have plenty of experience of taking products to the US, so there’s nothing to fear! We can easily review your QMS and technical documentation to carry out a gap assessment and reveal which areas need work. AND we can help you to produce the highlighted additional documentation or any necessary reformatting.

If you would like to talk to us about what you need to do to meet the US requirements, just give us a call on 01295 724286 or email to hello@imedconsultancy.com.