A Guide to Medical Device Marketing

Are you looking to bring a medical device to the market in the United States? Navigating the FDA’s complex regulatory process can be intimidating, but it doesn’t have to be.

Submit Your Premarket Submission and Communicate With the FDA

Four Steps to Bring Your Medical Device to the Market

Step One: Classify Your Device and Understand Applicable Controls

Before you begin the regulatory journey, perform medical device market research to determine how the FDA has classified your device. With stringent regulations governing the sale of medical devices, you must be sure to understand the risks associated with yours, and choose the right marketing pathway to ensure safety and effectiveness.

Medical devices on the market in the U.S. are categorized into one of three classes based on the level of patient risks they present:

Class I: Minimal potential for harm.
Class II: Moderate risk potential for harm.
Class III: Unreasonable potential risk of illness or injury, typically sustaining or supporting life or requiring to be implanted in the body.

As device classes increase, so do the FDA’s regulatory controls. That means that class I devices must meet the fewest regulatory requirements, class II’s have more moderate ones, and class III must undergo the most strict of assessments and evaluations for market approval. The FDA provides resources to help you determine your device’s classification.

Step Two: Choose and Prepare the Correct Premarket Submission

Once you’ve determined your device classification, you’ll be able to select and prepare the correct premarket submission, if one is required. Most types are listed on the FDA’s public Product Classification database. While there are exemptions for some class I and II devices, anything with those classifications are typically still required to comply with other regulatory controls.

The most common types of premarket submissions include:

510(k) (Premarket Notification)
PMA (Premarket Approval)

Some class I and most class II devices require a 510(k). To prepare this kind of submission, you must demonstrate that your device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing. The FDA offers resources on how to do so.

Class III devices require a PMA, which is the most stringent type of premarket submission. For the FDA to approve it, you must provide valid scientific evidence that your device is safe and effective based on its intended use. Here’s a resource from the FDA to help. You can also consider using the eSTAR interactive PDF form to help guide you through the preparation process.

How to Study and Market Your Medical Device

Step Three: Submit Your Premarket Submission and Communicate With the FDA

After you’ve prepared the appropriate premarket submission for your device, it’s time to send it to the FDA and communicate with their staff during the review process. Here are a few things to keep in mind before submitting:

User fees: Make sure to review medical device user fees, as they are typically required with certain applications.
Small Business Determination (SBD) Program: If your company is qualified and certified as a “small business,” you might be eligible for a medical device user fee reduction.
eCopy: Confirm whether you need to send an electronic version of your medical device submission.

Once the FDA receives your premarket submission, their staff conducts an administrative review to determine if the 510(k) or PMA submission is sufficiently complete before it’s accepted for a substantive review. During this process, FDA staff will communicate with you to maintain an efficient process. You can also send your submission and track the status online using the FDA’s Customer Collaboration Portal.

Manufacturing a new medical device starts with an idea, but after that, the medical device time to market process begins.

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Step Four: Comply with Applicable Regulatory Controls, Including Establishment Registration and Device Listing

The final step to bring your medical device to the market is to register your establishment with the FDA.

If you’re using contract manufacturing services, your manufacturer completes the registration process, which includes providing details about your device and the manufacturing procedures performed to develop it. As your manufacturer of record, the company will provide the FDA with details that ensure your device is made in accordance with Good Manufacturing Practices and labeled using FDA guidelines.

Helping You Bring Your Medical Device to Market

Remington has been through the premarket submission process for our own line of disposable medical devices. That means we know a thing or two about bringing new medical supplies to the market. Whether you want to launch something new or update what already exists, we take care of everything, from conception to registering with the FDA, to ensure everything succeeds according to plan. Contact us today to learn more.