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What You Need to Know About the FDA 510(k) Premarket Notification Process

So you want to get a new device on the market. How do you start the approval process? An FDA 510(k) (Food and Drug Administration) premarket notification grants you the ability to market your medical device in the United States. But before you can submit a notification, you have to know the class of your device because not all devices need to submit an FDA 510(k).

Medical Device Classification

Before you can get your medical device cleared/approved, you must determine your regulatory strategy. This helps define the regulatory path you must take. Part of this process is classifying your medical device between Class 1, Class 2 or Class 3.

Medical devices are placed into three different classes to better address regulatory requirements and the risk level of the device. Medical devices are classified by the Center for Devices and Radiological Health (CDRH) at FDA from certain criteria, including risk, invasiveness, and impact on patient health. Some exclusions apply in each classification making a premarket notification not needed.

Class I Devices

Class I devices are the fastest and easiest group to bring to market. They have the lowest risk to the patient and are not intended to support or sustain life. 47% of medical devices on the market fall under Class I (source:, but the majority are exempt from the regulatory process.

Class I Devices Include:

    • Cot
    • Standard Wheelchair
    • Oxygen Mask
    • Electric Toothbrush
    • Bandages and Gauze
    • Manual Stethoscopes
    • Protective Restraints

Class II Devices

Most reviewed and approved devices on the market are considered Class II. They are slightly more complicated than Class I and have a higher risk. They typically have sustained contact with patients, sometimes coming into contact with a patient’s cardiovascular system or internal organs. 

Class II is subject to more than just general controls like device performance, postmarket surveillance, labeling, and premarket data. By Class II definition, these general controls are insufficient to provide reasonable assurance of the device’s safety and effectiveness. Because of this, Class II is also subject to special controls, including special labeling requirements, patient registries, and performance standards.

Class II Devices Include:

    • Blood Pressure Cuffs
    • Surgical Gloves
    • Contact Lenses
    • Catheters and Syringes
    • Powered Wheelchairs
    • Pregnancy Tests

Class II devices may be moved up to Class III if the submitter cannot provide substantial equivalence to a predicate device. In these cases, a De Novo classification is a risk-based assessment that can help gain approval. 

Class III Devices

Due to the strict guidance for industry standards, Class III devices only make up 10% of medical devices on the market. They typically support or sustain life, have a high-risk factor, or are implanted into the patient. This classification is generally reserved for permanent implants, smart medical devices, and life support systems. This class of devices requires a Pre-Market Approval (PMA) submission to the FDA.

Class III Devices Include:

    • Pacemakers
    • Implants¬†
    • Ventilators
    • Defibrillators
    • Coronary Stents

For additional information, reference FDA guidance documents.

What Is a Premarket Notification?

Depending on the class of your medical device and the determined regulatory pathway, you may need to submit a 510(k) that is not subject to premarket approval. The premarket notification 510(k) is a required regulatory submission to FDA for companies to market a medical device in the United States. The requirements are identified in Section 513 of the Federal Food, Drug, and Cosmetic Act. A new 510(k) may be required when a change to the device affects safety, effectiveness, or intended use.

Finding a Predicate Device

In order to have a successful premarket notification 510(k) submission, you must demonstrate that an already legally marketed device has substantial equivalence (SE) to your product and has the same intended use. Substantial equivalence does not mean identical! If an FDA 510(k) review finds that the device is not substantially equivalent (NSE), another regulatory pathway must be determined.

FDA maintains an electronic database of 510(k)s cleared by the FDA. This database is searchable by device classification, regulation number, 510(k) number, device name, applicant, product code, date 510(k) received, 510(k) decision date, decision summary and statement. The database also allows you to view details on premarket notifications to determine an appropriate predicate device for your 510(k) premarket notification submission to FDA.

Predicate devices don’t have to be exactly the same, but most similar for the device under review. The submitter must show the new device is at least as safe and effective as the predicate. Marketing clearance is easily given if shown to have the same intended use and technology. However, it may be cleared if it has the same intended use as the existing device, even if it has modern technological characteristics. U.S. Food and Drug Administration staff will clear the 510(k) as long as the device is as safe and effective as the predicate and raises no new questions of safety and effectiveness.

Need an FDA Interpreter?

When you’ve found or invented the next great medical device, don’t let FDA regulations get in your way. At A Wright Path, we can help you submit an FDA 510(k) premarket notification and get your product to market as soon as possible. After approval, we have other long-term solutions to ensure your manufacturing and post-marketing processes always meet regulatory requirements and pass FDA inspections. Wherever you are in the process, schedule a consultation today to see how we can help.

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