Medical Device Regulation: An Overview

The Food and Drug Administration (FDA) regulates all medical devices in the United States to make sure they are safe and effective. These regulations are a critical part of the medical device development process, and they will likely influence the design and testing of new medical devices.

Navigating the medical device regulation process is complicated, and if you don’t correctly adhere to the applicable policies, your device may not make it to market or be forced into a recall after entering the market.

in2being can help the medical device development process. Our team is experienced in all stages of this process, including meeting medical device regulation requirements. If you have questions about medical device regulations or if you want to set up a consultation, don’t hesitate to contact us. We’re in this together.

FDA Regulations for Medical Devices

The FDA labels medical devices with one of three broad classifications: Class I, Class II, and Class III. A device’s medical device classification informs manufacturers and distributors of the level of regulatory control required for the device. Regulatory control increases with class number—in Class I devices generally have the least amount of restrictions while Class III devices have the most.

The Code of Federal Regulations (CFR) details the FDA’s medical device regulations. The CFR’s six basic regulation categories govern medical devices that are legally marketable in the United States. The level of scrutiny applied to a device by each regulatory category depends on the device’s classification and purpose.

Establishment Registration and Medical Device Listing

Manufacturers and initial distributors of medical devices must register their business or organization with the FDA before they can introduce their product to the market. Foreign manufacturers are required to have an agent in the United States throughout this process.

Following establishment registration, manufacturers must list all their medical devices with the FDA. A variety of details concerning each device should be included. This may include a 510(k) or Premarket Approval (PMA), depending on the device classification.

As part of this FDA registration and listing process, manufacturers must pay an annual fee to the FDA.

Premarket Notification 510(k) or Premarket Approval (PMA)

Most medical devices cannot be marketed in the United States without clearance or approval from the FDA. Premarket requirements for medical devices come in one of two forms: the submission of a Premarket Notification 510(k) or a petition for PMA.

Class I and Class II medical devices that are similar to other devices already in commercial distribution in the United States likely only require a 510(k). However, note that the 510(k) process is a clearance process rather than an approval process, so medical devices in this category cannot be advertised as “FDA-approved.”

Class III medical devices or products newly introduced to the commercial market in the United States require a petition for PMA. These devices require stricter regulations because they pose significant risk of injury or harm as a Class III device. A Class I or II device with no equivalent on the market would also call for further scrutiny.

Premarket Notification 510(k) is the fastest and most economical of the premarket requirement options. PMA, on the other hand, is a more involved process that includes the submission of clinical data. Your product’s category will be determined by its intended use and product code.

De Novo is an application sent by medical device sponsors to the FDA. De Novo classification uses risk-based strategy for new devices whose type have not yet been classified. If granted by the FDA, a new device type is established along with classification. Regulation and necessary controls are also established. De Novo does not typically warrant a Class III designation as a new classification regulation is developed through the process.

Investigational Device Exemption (IDE)

For PMA or, in some cases, 510(k) clearance, the FDA requires the submission of clinical data to verify the safety and effectiveness of the medical device in question. Manufacturers can gather that data with an investigational device exemption (IDE).

IDE is a process that allows manufacturers to use the medical device in studies to collect the data needed to support premarket approval. Studies with a lower level of risk only need approval from the Institutional Review Board (IRB), while studies with a higher level of risk need both IRB and FDA approval.

Quality System (QS) Regulation

Quality system (QS) regulatory requirements for medical devices cover a wide variety of QS controls, such as manufacturing facilities, installation procedures, and storing methods. The purpose of this regulation is to ensure medical devices consistently meet FDA requirements.

Since these regulations cover several different types of medical devices, there is no set QS for medical device manufacturers to follow. Instead, the FDA provides a framework called Current Good Manufacturing Practices (CGMP) or Good Manufacturing Practices (GMP).

Medical device distributors and manufacturers should follow the CGMP framework and apply the sections of the QS regulation that are applicable to their specific product.

Labeling Requirements

Labels are required for medical devices.

Medical devices have mandatory labeling requirements to meet not only for the labels on each device but also the descriptive literature of the device. FDA labeling requirements include details such as the use of symbols on labels and in literature. Since your product’s labeling is considered part of your device claims, it is a critical part of the development process.

Medical Device Reporting (MDR)

Medical device reporting (MDR) is a system used by the FDA and manufacturers to identify and keep track of medical devices that have caused patients harm or negative side effects.

Both manufacturers and importers are required to report deaths or injuries and certain malfunctions associated with medical devices to the FDA’s MDR program. With consistent and accurate reporting, the FDA can notify the marketplace of any issues with a device and avoid further problems.

How in2being Can Help Throughout the Medical Device Regulation Process

in2being specializes in helping businesses and individuals navigate the medical device development process. We can help you navigate FDA clearance protocols, marketing requirements, and regulatory processes. With our holistic approach and experienced leadership, in2being is ready to help. Contact us today to learn more.