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This video is part of an ongoing series of “droplet” videos intended to communicate key concepts in the medical device development process.

Video Transcript

Medical device startups speak of having a “regulatory roadmap.” Unfortunately, this critical step is often treated as a one-time, static analysis completed by a “regulatory expert” rather than an interactive resource that is understood by the development team. The FDA freely provides the databases to perform such roadmap analyses. Having a knowledgeable person review and confirm your analysis is important, but a regulatory roadmap is something your company must own, master, and live with throughout the development process.

To classify your medical device and start to understand its regulatory roadmap, it helps to know that FDA has grouped some 1700 generic device types into 16 medical “panels.” For example, certain patient monitors are in the “general hospital” panel, while a pulse oximeter is classified under the “cardiovascular” panel. Placing yourself into the correct “bin,” either informally or formally through the 510(k) substantial equivalence process, is at the heart of the primary FDA regulatory process.

Additionally, it’s important to know that FDA classifies devices into one of three regulatory classes: class I, class II, and class III. These classes are based on product risk.

All classes of devices require the application of “general controls” that were established in 1976 as amendments to the Food, Drug, and Cosmetic (FD&C) Act. They contain requirements concerning adulteration; misbranding; device registration and listing; premarket notification (submission of 510(k) application for “substantial equivalence”); banned devices; notification; repair, replacement, and refund; records and reports; restricted devices (prescription use); and good manufacturing practices (otherwise known as QSR, cGMP, or just GMP).

Depending on the specific device, parts of general controls may be exempted. For example, many class I devices are exempt from GMP, creating an easier pathway.

Many class II devices require “special controls” in addition to general controls. These ensure safety and efficacy when general controls alone are insufficient. As the FDA says, “Special controls are usually device-specific and include: Performance standards, Postmarket surveillance, Patient registries, Special labeling requirements, Premarket data requirements, and Guidelines.”

Finally, class III devices normally require a pre-market approval (PMA) submission to FDA in addition to general controls. PMAs are outside the scope of this video, but keep in mind that any company embarking on a class III development project has undertaken the highest level of FDA scrutiny and associated costs.

Sometimes, a novel device will not fit within the existing regulatory classifications, nor will it have a suitable predicate device for substantial equivalence. This device may require a De Novo submission (which is the subject for another video).

In order identify which panel, regulation number, and product code your device may fit under, along with associated regulatory requirements and exemptions, you can search the FDA classification database by keyword. You can also skim through the classification panels directly, looking for appropriate categories for your device.

And in2being’s Pathsurveyor tool brings many of these FDA resources together in a single search bar format. Pathsurveyor is a great tool for finding related devices and historic clearance times for 510(k) devices.

Ultimately, your goal is to narrow down to one or more product codes which adequately describe your device’s intended use. The FDA page for a specific product code lists the primary regulatory milestones, such as whether your device requires a 510(k) or GMP.

Sanity check your findings with someone knowledgeable in the regulatory space, and consider submitting a 513(g) Request for Classification directly to FDA for confirmation. Feel free to reach out to in2being for assistance in either of these areas.

Contact us to learn how in2being can be your medical device development partner. Additionally, you can view our video about FDA registration and FDA approval vs. clearance.

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