FDA Publishes De Novo Classification Proposed Rule

Getting a medical device approved for market use by the Food and Drug Administration (FDA) can take at least several years. However, there are ways to expedite the process. One is the De Novo Classification Proposed Rule, which was published on December 4, 2018.

The De Novo pathway was created for novel medical devices that are safe and effective and can improve the health of patients. The FDA conducts a rigorous review of these new technologies and will assure that they are safe before allowing them to be sold on the market. The FDA wants these devices to be used in a timely manner – not years down the road.

The De Novo pathway is used for new medical devices that are not similar to anything else on the market, unlike the 510(k) process, which requires a device to be similar to an existing device. The pathway establishesa basis for modern standards for performance and safety so that future clearances can occur. The goal of the De Novo pathway is efficiency, as it clarifies the submission requirements and informs submitters of the review processes.

The De Novo Classification Proposed Rule is currently available for public comment. It is not yet finalized, but once it is, it will become part of the Medical Device Classification Procedures.

De Novo classification has been around since 1997. Since then, 235 devices have gone through this process. Most of these – 170 – occurred after 2012.

What is the 510(k) Process?

At the same time, the FDA is also making changes to its current 510(k) processes. A 510(k) is a submission made to FDA demonstrating that the device is at least as safe and effective as a legally marketed device. This expedited process allows for a quicker approval of medical devices with a low to moderate risk that are similar to devices already on the market. Before marketing a device, the submitter must receive a letter from FDA stating that the device can be marketed in the U.S. This letter allows for commercial distribution.

On average, it takes a medical device 177 days to be approved via the 510(k) process. That’s a little under six months. Using the traditional process, it can take 3-7 years. This can make it difficult for patients to obtain the devices and medications they need in a timely manner, which is why the FDA allows for quicker processes.

Nadrich & Cohen Representing Victims Injured By 510(K) Approved Devices

Nadrich & Cohen and its legal teams have represented thousands of defective medical device victims and their families. Many victims were hurt by devices which were approved through the 510(K) process, such as the Essure birth control device.

Our injury attorneys represent victims and their families solely on a contingency fee basis. We offer a free consultation. Phones and live chat are answered 24/7.


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