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Clinical evidence for Class II medical devices in EU and US


Involved In Discussions
Dear Experts,

I have few questions related to medical devices regulations in US or EU or across different geographies.

1. How does having EUCER for medical devices at first help obtaining 510(k) or PMA smoothly in US or any other countries. Does CER really help in getting clearance in countries like US. If yes, it would be great if you could explain how?

2. It is my understanding that not all class I and class II devices in US requires clinical evidence unlike EUMDR where the device under evaluation require clinical evidence irrespective of the class of the device.

3. On what basis FDA provides 510(k) clearance for Class II devices without clinical evidence?

It would be great if you could answer these questions or provide a relevant link to find answers.

Many Thanks in advance!

Michael Malis

Quite Involved in Discussions
CFR 800 is the best reference for Class 1 and Class 2 requirements.
You need to show DATA for product equivalence - this can be a bench test for simple devices and/or clinical data for more sophisticated.
Clinical study for safety evidence, risk analysis and biocompatibility of materials may also needed.
The information in the CER might be helpful, but the CER itself, probably not. It is impossible to say whether the information will be helpful without looking at the device, the information in the CER, and also determining whether the device is a 510(k) or PMA (or perhaps De novo) device. If it is a 510(k) device, the nature of the predicate must also be considered.

FDA will clear a Class II device via 510(k) without clinical evidence if it determines that clinical evidence is not necessary to show substantial equivalence to a predicate device, and, in many cases, to also show that the 510(k) device is at least as safe and effective as the predicate device.

Less than 10% of 510(k)s cleared in the last few years were supported by a CLINICAL TRIAL. Whether this refers only to clinical trials sponsored by the applicant for the express purpose of supporting the 510(k), or clinical trials conducted independently and reported in the literature, I can't say for sure, but probably they were the former. Whether the 510(k)s not supported by clinical trials included some other type of clinical evidence, it is very likely that some of them did, but what percent of these 510(k)s included some other type of clinical evidence, I can't say. Whether the clinical evidence was included because it was necessary to support clearance, or whether the applicant had collected it for other reasons and included it just because it was available, I can't say.

FDA's regulatory framework is far more device-specific than that of most regulatory jurisdictions. There is a very limited amount of information that applies to all devices, or even to all 510(k) devices or all PMA devices.

My preferred resource for these types of questions is FDA's 510(k) database, which includes summaries of the data that were submitted for most of the 510(k)s FDA has cleared:

510(k) Premarket Notification

If you can identify one or more potential predicates for your device, and a data summary has been posted, it might give you some idea of FDA's expectations for this device type. However, since the data requirements are not determined by the predicate alone, but by the similarity between the predicate device and the 510(k) device, FDA's expectations might be different for your device.

You might also search FDA's guidances to see if it has issued one for your type of device:

Guidance Documents (Medical Devices and Radiation-Emitting Products)

Ronen E

Problem Solver
Staff member
Super Moderator
My preferred resource for these types of questions is FDA's 510(k) database, which includes summaries of the data that were submitted for most of the 510(k)s FDA has cleared
The contents, format, and level of detail in these summaries vary a lot, and unfortunately the useful information (in this discussion's context) in many is very limited. But I do agree that this is generally a useful resource and one of the first places I would check.
Agreed. The information can also be cumbersome to access. A lot of clicking, plus a limited number of search options, in part because a lot of the best information is trapped in unsearchable PDFs.

I think this database is practical to use only if you can narrow down your search, usually to your device type. I also think it is useful only if a number of potential predicates have been cleared fairly recently. Otherwise, FDA's expectations have probably changed.

In the end, the best information Tiffany88 might get from these links is a better understanding of the complexities involved in FDA clearance or approval.
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