An Overview of Medical Device Regulations

The FDA regulates establishments that manufacture, repackage, relabel, or import medical devices sold in the United States. These regulatory measures help to ensure the safety and efficacy of medical devices and the country’s ability to respond promptly to public health emergencies. Read this overview of medical device regulations to understand the requirements that manufacturers and distributors must meet.

Risk-Based Classification System

The FDA classifies medical devices into three categories, and a major factor for the basis of classification is the risk the device poses to the patient or user. Class I devices are associated with the lowest risk, Class III devices are associated with the highest risk, and Class II has a risk level that falls between the two.

A device’s class determines the type of premarketing submission the FDA requires to grant approval to the US market. The premarketing submission helps determine the device’s safety and efficacy.

Most Class I devices are exempt from the premarketing submission requirement; however, all devices are subject to exemption limitations. Most Class II devices require a premarket submission. All Class III devices are subject to premarket approval requirements.

510k Premarket Notification

A 510k is a premarket submission demonstrating that the device is safe, effective, and substantially equivalent to a legally marketed device; this legally sold device is the “predicate.” The submitting manufacturing or importing establishment must compare their device to one or more similar legally marketed devices.

Often, establishments choose devices recently cleared under 510k as the predicate to which they argue equivalence. But establishments can use any legally marketed device as a predicate. Legally sold devices cannot violate the Federal Food, Drug, and Cosmetic Act.

The establishment may not legally market the product until they receive the FDA’s declaration of their device’s substantial equivalence to the predicate. The FDA usually issues its determination within 90 days, and they make the decision based on the information the establishment submitted.

Claiming Substantial Equivalence

The claim of substantial equivalence doesn’t mean that the new and predicate devices are identical. One way the FDA may determine whether a device is substantially equivalent to the predicate is if the new device has the same intended use and characteristics as the predicate.

If the device has the same intended use as the predicate but different technological characteristics, these differences must not create questions about the safety and efficacy of the product. Additionally, the production or distribution establishment must submit information to the FDA that demonstrates the device is as safe and effective as the legally marketed device.

Establishment and Device Registration

Domestic and foreign manufacturers and importers of medical devices must register with the FDA. These establishments must submit their registrations electronically unless the FDA granted a waiver. Additionally, foreign manufacturers must designate a US agent.

The US agent must either reside in the US or maintain a business in the US. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The US agent helps in communications with the foreign manufacturer. They respond to questions regarding devices and assist the FDA in scheduling inspections. The US agent will also accept information or documents from the FDA if the FDA cannot contact the establishment directly or promptly.

Establishments involved in producing and distributing medical devices for use in the US must also register the device annually with the FDA. Usually, they must list the devices made at the establishment and activities performed on the devices. Registration and listing inform the FDA of the location of establishments and their devices, and this information can improve the government’s ability to respond to public health emergencies.

Quality System (QS) Regulation

The quality system (QS) regulation states requirements for designing, manufacturing, packaging, labeling, purchasing, storing, installing, and servicing medical devices. The FDA inspects manufacturing facilities to ensure compliance.

The QS regulation applies to many different devices, so it cannot give detailed, prescriptive guidelines for manufacturers’ production of specific devices. Instead, manufacturers use the regulation as a framework. They must use good judgment when developing their quality system and apply applicable sections of the QS regulation to their products and operations.

Labeling Requirements

The FDA follows the Federal Food, Drug, and Cosmetic Act (FFDCA) to state legal requirements for labels on devices and descriptive and informational content that come with the device. Content includes information in posters, pamphlets, tags, booklets, brochures, and more.

The FDA’s requirements cover directions for use, misleading statements, symbols in labeling, and more situations. Accurate and thorough labeling educates patients and providers on the use and maintenance of the device and associated risks.

Medical Device Reporting (MDR) Regulation

The Medical Device Reporting (MDR) regulation states mandatory requirements for manufacturers, importers, and facilities that use devices to report some device-related adverse events and product problems to the FDA. Since February 14, 2014, manufacturers and importers must submit MDRs to the FDA electronically for processing, reviewing, and archiving.

The MDR regulation supports the FDA and manufacturers in detecting and monitoring significant harmful events involving medical devices. The information helps to correct problems promptly.

Manufacturers must report to the FDA if they learn about any of the following situations.

  • Any of their devices may have caused or contributed to death
  • Any of their devices may have caused or contributed to serious injury
  • Any of their devices have malfunctioned, and a recurring malfunction would likely cause or contribute to death or serious injury

Importers must report to the FDA and the manufacturer when they learn a device may have caused or contributed to serious death or injury. In the case of a dangerous malfunction, the importer must only report to the manufacturer.

User facilities must report suspected device-related deaths to the FDA and the manufacturer. User facilities must report serious injuries to the manufacturer.

If the manufacturer is unknown, the user facility must report the serious injury to the FDA. User facilities can voluntarily report a device malfunction through MedWatch, though it is not a requirement.

This brief overview of medical device regulations in the US shows the lengths to which the FDA, manufacturers, importers, and facilities go to ensure medical equipment is safe. All States M.E.D. is a proud supplier of medical equipment in Miami. Shop with us today for ultrasound equipment, electric exam tables, autoclaves, and more.

An Overview of Medical Device Regulations