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Taking the first steps toward FDA approval for your innovative medical device

Deanna Pogorelc

You’ve heard about the complex process of securing U.S. Food and Drug Administration approval for your new medical device, and about the back-and-forth between the FDA and industry regarding approval reform. But for now you just need to know which path your device will need to follow, how long it will take and how you begin the process.

Medical devices are separated into three classes: Class 1, or low-risk, devices; Class 2 devices, which could cause harm to patients if they malfunctioned or were misused; and Class 3 devices, which are high-risk and could severely endanger a patient if they malfunctioned or were misused.

Most Class 1 devices don’t require approval but must be registered with the FDA. Class 2 devices must undergo the 510(k) process, which requires submitting a detailed pre-market notification that can take months to prepare. Once it’s submitted, an FDA staffer is expected to complete the review within 90 days, but in many cases this can drag on if the reviewer has questions or if you submitted incomplete data. The Emergo Group recommends allowing at least four months for this process.

For a Class 3 device, you will need to submit extensive clinical trials, which could take three or more years.

To determine what class your device fits into, visit www.fda.gov/medicaldevices and search for “product classification” to find a product that closely matches yours.

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