Medical Device Classification & 510K

Bringing a new medical device to market is exciting as long as you understand medical device classification & 510K. You have an innovative idea or a new twist on existing technology, and now it is time to start marketing it and helping people.

It is also the time to get with a Food and Drug Administration (FDA) attorney to ensure that you have a plan for clearing all the hurdles the FDA will place in your path.

Medical Device Classification & 510K Premarket Clearance

The FDA categorizes medical devices into three basic classes: Class I, Class II, and Class III. The FDA distinguishes these classes based on the level of control required to ensure the safety and effectiveness of the device, with Class III requiring the most controls. The FDA has issued scores of classifications into the regulations that cover most devices. The key to classification is finding which classification (or classifications) your device fits into.

Unless exempt, all medical devices require a premarket clearance (Premarket Approval Application (PMA), 510k, or De Novo). Premarket notification is expensive and time-consuming, with PMA being the most expensive. Therefore, the first thing a marketer of a new medical device needs to do is determine the device’s classification.

We can help you classify your device and identify the easiest path to market. In some cases, adjusting your marketing approach can change the classification and help you avoid a more expensive premarket clearance process. Together, we can develop a strategy to get you to market quickly and affordably.

Medical Device Classification & 510(K) Terms to Familiarize Yourself With
Learning these terms will help you understand the process of resolving your FDA Detention.

Medical Device – An instrument that is intended to treat disease and/or affect the structure or function of the body. It is distinguishable from a drug because it does not achieve its primary intended through chemical effect on the body or through metabolism.

Intended Use –  The objective purpose of the person responsible for labeling the medical device. The FDA can infer intended use from any relevant source, such as the device label, labeling, promotional materials, and website.

Class I Exempt – This class of medical device does not typically require premarket clearance. There are many types of Class I Exempt devices, but some examples include toothbrushes, electric massagers, and regular adhesive bandages. Devices in this category can become non-exempt (i.e., requiring a 510k) when they are marketed for uses beyond those described in the classifying regulation.

General Wellness Device –Low-risk instruments that are intended to affect the body, but that the FDA does not intend to regulate as medical devices. These devices are intended for general wellness, meaning that they are for the maintenance of health or for encouraging healthy behavior. Examples include devices intended to help with weight loss, sleep management, sexual function (not dysfunction), or relaxation.

510k – A premarket notification that is required for non-exempt medical devices that are not class III. A successful 510k notification will demonstrate to the FDA that the proposed medical device is substantially equivalent to an already FDA-cleared device, called a “predicate device.” If the FDA finds that the device is substantially equivalent, then you can begin marketing it. If the FDA does not find the device substantially equivalent, then you must either file a De Novo review or PMA. See below.

De Novo – A filing for low-to-moderate risk medical devices that were subject to a failed 510k or that are known to have no predicate device. The De Novo process is similar to the 510k.

PMA – A Premarket Approval Application that is for Class III medical devices.

Registration & Listing – Where device manufacturers and initial importers must register with the FDA and pay a substantial fee ($4,884 for 2019). Manufacturers must also list each medical device that they market with FDA.

How an FDA Attorney Can Help
We can help you classify your medical device and develop a pathway to market. We will help you with the following:
  • Classify your medical device and if necessary, petition the FDA for its opinion.
  • Help you find the easiest and least expensive path to market.
  • Identify and help you evaluate the risks in the process as you near marketing your medical device.
  • Review your labels and marketing to make sure you stay within your classification.
  • Work with your team in developing and filing any necessary premarket notifications.
  • Represent you to the FDA before, during, and after the premarket process.
  • Assist you with import or domestic enforcement issues.

We understand the medical device marketing process and we understand the FDA. We will be there for you.

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