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Gaining Market Approval for Medical Devices

FDA Market Approval

It is the responsibility of manufacturers to ensure the products they bring to market are safe for public use. While the US FDA reviews the products before going to market, what do medical device manufacturers do to gain market approval?


Classification for Marketing

The FDA uses a risk-based, tiered approach for regulating medical devices, classifying them as either Class I, II or III. The class a medical device is assigned determines the type of premarketing submission/application required for FDA clearance to market.

Classification categories include:

  • Class I devices, typically low risk devices
  • Class II devices, typically moderate risk devices
  • Class III, defined as high risk devices

Although the FDA will give the official classification during its review, the medical device manufacturer can help the FDA by selecting the classification for its product based on the federal regulations for the device.

Manufacturers can find the classification along with any exemptions that may exist by going directly to the classification database.

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Premarket Submission Regulation

Once classified, the correct required premarket submission regulation must be followed.

Each premarket submission has its own requirements for what must be submitted. Once the premarket submission is ready, it is sent to the FDA for review.

The manufacturer will then register the establishment and its devices with the FDA; however, if the product needs premarket approval or clearance, it cannot be added to the list until FDA approval has been received. It is important to note that just because there is a registration of establishment and device, it does not mean that it has been cleared or approved by the FDA.


Defective Products

Products that are later found to be defective can cause serious injuries to patients. It is up to the FDA to take some kind of action, such as a public warning, putting a black box warning on the device or recalling the device.

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Legal Expertise for Medical Device Injuries

The attorneys and legal team at Nash & Franciskato Law Firm in Kansas City are dedicated to representing people seriously injured by defective products. If you’re ready to speak with an attorney, contact the experienced attorneys at Nash & Franciskato for a free, no-obligation review of your case. They will help you understand your legal options.

Our knowledgeable staff is available at (877) 284-6600.

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