The FDA Regulatory Pathway for Premarket Notification 510(k)

The FDA regulatory pathway for Premarket Notification 510(k) is required by anyone who intends to market a Class I, II, or III device in the United States intended for human use, for which a Premarket Approval (PMA) is not required, unless the device is exempt from 510(k) requirements. The 510(k) is a premarket submission made to the FDA which is meant to show that the device is at least as safe and effective to an existing device.

The Premarket Notification 510(k) process can be complex and it should be well understood before embarking on a new product launch in the medical device industry. Every medical device product will have some unique characteristics that need to be carefully considered and planned in order to successfully navigate this process.  Through our work at Boyd Biomedical, we've gained valuable insight into the process. Below is a brief overview of the main steps in the FDA regulatory pathway for Premarket Notification 510(k).

• Device Classification
• Predicate Device
• Guidance Documents
• 510 (k) Submission
• FDA Review
• Device Registration

Device Classification

The first step in the 510(k) process is to confirm that your product is a medical device and that it qualifies for Premarket Notification. The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as device classification panels.

Go to the classification database and search for a part of the device name, or, if you know the device panel (medical specialty) to which your device belongs, go directly to the listing for that panel and identify your device and the corresponding regulation. Once you know that your device qualifies for Premarket Notification and have identified its classification and regulation you can get started.

Predicate Device

A Premarket Notification 510(k) submission to the FDA is based on a comparison of your device to another medical device that has already been cleared by the FDA. This is called the Predicate Device. The goal of the 510(k) submission is to show that your device is at least as safe and effective as the Predicate Device. The FDA calls this "substantial equivalence".

The best way to find predicate devices is to search the FDA product code classification database. The classification database will provide the classification panel, common name, product code, and CFR regulation. In many cases, you will already be familiar with potential Predicate Devices so you can navigate through the classification database efficiently. 

Watch our video series about biomedical innovation.

Guidance Documents

Using the Product Classification Code for the predicate device, it is important to search and find any special guidance documents or international standards that apply to your medical device. These guidance documents could relate to particularly important aspects of your device, such as

• electrical safety
• or, software validation

These are additional requirements you must meet as part of the 510(k) process. You can search for documents here, by key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

Guidance documents can be tricky to navigate and address because they simply represent the FDA's current thinking on a topic. These documents do not bind the FDA or the public, so there is some level of interpretation left open. You are free to use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Nonetheless, it is worth spending some time to understand this area of the Premarket Notification 501(k) process. 

510 (k) Submission

After one or more predicate devices have been identified, and after all safety and performance testing is finalized on your finished product, you must prepare and submit the 510(k) to the FDA, comparing your device to the predicate(s).

It is worth noting the timeline at this point to medical device manufacturers. A finished product must be manufactured, then tested, with all the appropriate documentation gathered before even submitting a 510(k). This fact can often surprise product development teams when they have planned aggressive product launch dates.  Be careful to consider how long the complete process to launch a medical device product can take. 

The 510(k) submitter must submit two copies of the 510(k) to CDRH’s Document Control Center (DCC), one of the two copies must be an electronic eCopy. A general overview of the 510(k) submittal process can be viewed here.

FDA Review

The FDA has a goal of reviewing submissions within 90 days, but that timeline can vary by product. On average, it takes about 135 days from the time you submit your 510(k) to the FDA for review, until it is cleared by the FDA. The FDA charges a fee to review your submission. If successful, you will receive a 510(k) clearance letter from FDA with your 510(k) number.

Opinions and data on the FDA review period vary. This recent Qmed article"The Top 10 510(k) Trends Since 2000"  is a great reference. In it, Brian Buntz explains:

"Although the average time for FDA to clear a 510(k) application has been trending down in recent years, it had increased by 60% from 2000 to 2010, increasing from an average of 96 days in 2000 to 154 in 2010. Interestingly, the FDA’s data indicates that the delay was largely a result delays on the part of the submitter."

BRIAN BUNTZ

Device Registration

Businesses, the FDA calls them establishments or facilities, that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. This process is known as establishment registration, you can find a guideline here.

The FDA collects an annual registration fee for device establishments. The schedule of annual registration user fees for fiscal years 2013 through 2017 can be viewed here.

Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. Once your medical device has been cleared and you have received your 510(k) number, you will need to register your device with the FDA.

Conclusion

The FDA regulatory pathway for Premarket Notification 510(k) is required by anyone who intends to market a Class I, II, or III device in the United States intended for human use, for which a Premarket Approval (PMA) is not required, unless the device is exempt from 510(k) requirements. The Premarket Notification 510(k) process is complex and should be well understood before embarking on a new product launch in the medical device industry. These six steps in the FDA regulatory pathway for Premarket Notification 510(k) should be understood in order to successfully launch a medical device product.  

• Device Classification
• Predicate Device
• Guidance Documents
• 510 (k) Submission
• FDA Review
• Device Registration