Medical Devices

FDA Medical Device Regulation in the U.S.

Medical devices can be described as a variety of different products from toothbrushes to pacemakers. The Food and Drug Administration (FDA) considers anything intended to diagnose, treat, prevent, or cure disease, or change the body structure of humans or animals in a primarily non-chemical manner (i.e. not metabolized) to be a medical device. This includes radiation-emitting devices intended for medical use.

Medical devices that include drugs or biological products are combination products. FDA also considers software intended for medical purposes without being included in physical medical devices to be software as a medical device. FDA’s Center for Devices and Radiological Health (CDRH) regulates medical devices imported into or manufactured in the United States. Medical devices are regulated by CDRH according to their intended use.

FDA regulations require medical devices to be:

properly labeled,
manufactured according to specific standards,
to obtain pre-clearance before being imported,
and to be manufactured in registered facilities.

Free Facility Inspection Checklist

Device Classification

Medical devices are classified into one of three classes under the Food Drug and Cosmetic Act. They are classified based on their risk of harm, required control to use safely, and intended or labeled use. Manufacturers, importers, and distributors of medical devices need to understand these classifications, and how they apply to their products.

Class 1 medical devices present the lowest level of risk to the patient or user. Most Class 1 medical devices can enter the U.S. market by labeling the medical device correctly, registering the device manufacturer and other establishments in the supply chain, and listing the device with FDA.

Class 2 medical devices carry greater patient or user risks than Class 1 devices. Class 2 devices are moderate-risk devices because a failure or defect would present some level of harm or injury, but not serious injury and almost certainly not death to the patient or user. Most Class 2 medical devices submit a Premarket Notification (PMN) or FDA 510(k) before marketing the device (see below). More than half of all Class 2 medical devices are subject to the 510(k) clearance process.

Class 3 medical devices carry the greatest risk of the three device classifications. Failures or defects associated with Class 3 medical devices would pose significant risk of serious injury or even death to the patient or the user. Most Class 3 medical devices are subject to the Premarket Approval (PMA) process, which is substantially more complicated, costly, and comprehensive with regard to the evidence of safety and effectiveness FDA requires.

Devices that FDA has placed in one classification regulation may be moved to another (more favorable) classification if the manufacturer can present FDA with evidence and arguments to support reclassification.

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Registration & Listing

Medical device establishments that develop device specifications, manufacture, process, pack, assemble, label, and export or import medical devices must register with FDA. Before they can be imported or distributed in the U.S., the registering establishment must also list all medical devices (called a device listing).

Any medical device facility must be registered and listed annually. Foreign device establishments must also identify a US Agent for FDA purposes and list their devices before importing them into the United States. Products are subject to import detention if their registration or listings are incomplete or incorrect. FDA may delist (inactivate) products from their database when registrations are not renewed. Read more about registering facilities here.

Good Manufacturing Practice/ Quality System Regulations (GMPs/QSRs)

Most medical devices must be manufactured in accordance with FDA’s Quality System Regulations (QSRs). The QSRs represent the Good Manufacturing Practice (GMP) program FDA implements for medical devices in the United States, and they are the closest of all of FDA’s GMP regulations to the more internationally recognized International Standards Organization (ISO) process. However, in contrast to ISO, the FDA QSRs emphasize medical device design control procedures and device design history. To some degree, this distinction arises from the fact that FDA has separate approval or clearance processes that relate to device safety and efficacy. QSRs, therefore, aim to ensure that the manufacturing process can continuously produce the marketed device. Important aspects of the regulations are design control, corrective and preventative actions, and document controls.

510(k) Filings

For those medical devices requiring special controls in device design, manufacturing, and safe and effective use, a Premarket Notification (510(k) submission) is required. These medical devices typically represent moderate safety risks to patients and users. In the 510(k) filing process, the submitter must show that the subject device is substantially equivalent to a predicate device (a device that is already lawfully marketed in the U.S.).

Most Class 2 (and some Class 1 and Class 3) medical devices are subject to FDA’s submission process. Certain steps in the development and manufacturing process for medical devices trigger the requirement to prepare and file a 510(k). These submissions are required when a foreign manufacturer intends to export a medical device to the U.S. that the firm has never done so before; they are also used when changing the indication for use or significantly modifying a cleared medical device.

Labels

FDA is very specific about the labeling claims that may appear on medical devices. The information permitted on a medical device label is dictated by regulations governing the device. All medical device labels must contain a Unique Device Identifier (UDI) which is a special bar code that is unique to each medical device. FDA considers online marketing sites to be part of the label, and often reviews them looking for claims that exceed FDA regulations, clearances, or approvals. Devices with incomplete labels or with claims that exceed regulatory limitations (including online marketing) may fall into an unapproved category. Unapproved devices may be subject to FDA recall (mandatory recall), FDA import detention, FDA Import Alerts, and FDA import refusal of admission. Read more about labels here.

Need Help?

At FDAImports we have the expertise to navigate the complex regulations surrounding medical devices, and their importation. As medical technology advances, new medical devices more frequently fail to clearly fit within existing medical device categories. Our team can help classify new medical devices accurately, reclassify existing medical devices, and file 510(k) submissions. We can also help with labeling, QSRs, pre-clearance, registration of medical devices and facilities, and act as a US agent.