Everything You Need to Know About the New 510K Regulations (In 2 Minutes)

As you get close to the launch of your medical device, you need to consider many rules and regulations.

A significant one is 510k readiness. You may have filed for your 510K and are confident about its approval. But hold on to your horses before taking them for an award show.

This blog is meant to give you an overview of what 510k and what changes are in the FDA pipeline. Also, you will discover what this means for your marketing strategy.

What is 510k?
The FDA describes the 510K as follows: “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA (Pre Market Approval).”

So, if you are:

A domestic manufacturer introducing a device to the U.S. market
Specification developer introducing a device to the U.S. market
Repacker or relabeler who make labeling changes or whose operations significantly affect the device
Foreign manufacturer/exporter or U.S. representative of foreign manufacturer/exporter introducing a device to the U.S. market
This regulation should be on your radar.

Now, let’s figure out why the FDA is making moves to change this set of rules.

Why will there be changes to 510k?
The goal of the FDA is to make sure that when you submit a new device, it includes updated technology for enhanced functionality and patient care.

So, what does this mean exactly?

The FDA will compare your device with predicates that are no more than 10 years old. Or simply put 510K ‘modernization’ will “reflect advances in technology, safety and the capabilities of a new generation of medical devices.”

That isn’t too complicated. However, when it comes to promoting your device, there are several things to consider.

Is your Device Exempt from 510k?
Many Class I and Class II devices are exempt from the FDA 510K approval needs. By proposing this list, FDA stated that “FDA’s action will decrease regulatory burdens on medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation.” These are devices that are of low to moderate risk. Details and listing of 510K exempt devices can be found here.

Having your device on this list would save a lot of work. But it’s important to note your device may not be exempt from any other statutory or regulatory requirements and you must check with your regulatory personals for specifics.

How Do You Promote Your Device Before 510k approval?
If you want to market your device before approval, you are not the only one. However, if your device doesn’t have a marketing clearance the FDA considers it “investigational”. This means that you can’t fully promote your medical apparatus, nor can you advertise or sell it.

Nevertheless, you might still want to capitalize upon marketing opportunities like:

Annual trade shows
On-site demonstrations
Digital marketing campaigns
If you decide to engage in any of these, please be aware of the limitations set by the FDA. And, don’t forget to display the following sign:

“Pending 510k” along with clearly indicating that your device is not for sale in the United States.

How Do You Advertise Your Class 1 and 2 Devices?
Unfortunately, there is a lack of clarity as to what is needed if you want to advertise a class 1 or 2 devices. The rules FDA has on this are vague and they changed little after making them in the 1980s. For example, it’s not clear if you can promote the “device’s expected indications for use”, nor does it specify what activities constitute “preparing to take orders”.

Therefore, regardless of your situation, if your device is Class 1 or 2 it should always be labeled with:

Not available for commercial sale
If your device holds at least one cleared 510k indication and other, pending indications, you can only promote it for the cleared indications.

How Do You Advertise Your Class 3 Device?
If you promote your class 3 device, there are strict rules that limit the scope of endorsement. For example, for this category, you are not allowed to market your device as “safe” or “effective” till 510K is approved.

Important Closing Note
As you read now, the marketing of your devices comes down to following the guidelines set out by the FDA. Please, make sure that you stay up to date on the changing landscape of 510k approvals, and that you don’t violate any rules when you label your device.

Disclaimer: This blog post is not intended to be legal advice. The information in this blog post (“post”) is provided for general informational purposes only, and may not reflect the current law in your jurisdiction. No information contained in this post should be construed as legal advice from Bluecognos or the individual author, nor is it intended to be a substitute for legal counsel on any subject matter. No reader of this post should act or refrain from acting on the basis of any information included in, or accessible through, this Post without seeking the appropriate legal or other professional advice on the particular facts and circumstances at issue from a lawyer licensed in the recipient’s state, country or other appropriate licensing jurisdiction.

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