Medical devices are an essential component of modern healthcare, and their safety and efficacy are crucial for the well-being of patients. To ensure that medical devices are safe for use and meet certain quality standards, the Food and Drug Administration (FDA) in the United States regulates the marketing and distribution of medical devices. But the question remains, do all medical devices need FDA approval?
Do All Medical Devices need FDA Approval?
The answer is No, not all medical devices require FDA approval before they can be marketed and sold. The FDA regulates medical devices based on their risk level, with higher-risk devices requiring more scrutiny and regulatory oversight than lower-risk devices. The FDA classifies medical devices into three categories, Class I, Class II, and Class III, based on the level of risk they pose to patients. Class I devices are considered low-risk and do not require premarket review or clearance by the FDA. Examples of Class I devices include tongue depressors, elastic bandages, and manual wheelchairs.
Apart from regulating and supervising the safety of foods, dietary supplements, and a host of medical treatments which includes drugs, vaccines, cosmetics, etc, the FDA is also responsible for clearing & approving the usage of medical devices sold in the US. Center for Devices and Radiological Health (CDRH) is the body within the FDA responsible for this. It is accountable for overseeing the production, functionality, and safety of all medical devices as well as their premarket approval in the US.
But even after the best efforts of the FDA to make the process of bringing a new device to the market easy, many businesses find it confusing to figure out the correct process for their medical device, and if all medical devices need FDA approval in the first place or not.
This blog will help you answer that.
How does the FDA define medical devices?
To understand the approval process, we have to first understand what the FDA considers a medical device. Section 201(h) of the Federal Food, Drug, and Cosmetic Act tells us exactly that.
According to the FDA, “a medical device is any instrument, machine, contrivance, implant, or in vitro reagent that is intended to treat, cure, prevent, mitigate, or diagnose disease in man.” Examples range from a basic tongue depressor, thermometer, and bedpans to complex programmable pacemakers. A medical device does not accomplish its primary intended use by being chemically activated on or within the skin, and it is not necessary for it to be metabolized to accomplish that primary intended use, according to the definition. The FDA would regulate that product as a drug if it was either of those two.
How to Determine if a Product is a Medical Device according to the FDA
To determine whether a product is a medical device or not, FDA has provided the following steps that may be helpful in most cases:
Step 1: Determine if your product meets the definition of a medical device per Section 201(h) of the Food, Drug & Cosmetic Act
If a product satisfies Section 201(h) of the Food, Drug, and Cosmetic Act’s definition of a medical device, the FDA considers it to be a device and subject to FDA regulation.
You should specify the intended use and usage indications of your product to ascertain whether it satisfies the definition of a medical device. You can decide if your product fits the definition of a medical device once you’ve specified its intended use and usage indications.
Step 2: Determine if an appropriate product classification exists for your product
Searching for existing product classifications that might apply to your product can be helpful in determining whether your product is regulated as a medical device. A good indication that your product might be a medical device is finding an existing classification that describes its intended use or design.
Search the official FDA Product Classification Database to determine if there is an existing product classification that applies to your product.
Major FDA Regulations for Medical devices & their purpose
There are numerous individual FDA regulations with different purposes that Medical Device manufacturers have to adhere to. Depending on the particular medical device and which class it belongs to, it either needs one or a combination of multiple registrations, applications & approvals. Before we list out what is needed for every class of medical device, here is a brief description of the major FDA regulations:
The FDA also provides several pathways for medical device manufacturers to obtain approval or clearance for their devices, including the premarket approval (PMA) process, the premarket notification (510(k)) process, and the De Novo process.
The PMA process is the most stringent and is required for Class III devices and some Class II devices. The PMA process involves a detailed review of the device’s design, manufacturing, and clinical data to determine its safety and efficacy. The 510(k) process is a less stringent premarket review process for Class II devices and some Class III devices. Under the 510(k) process, a manufacturer must demonstrate that its device is substantially equivalent to a legally marketed device that was cleared or approved by the FDA before it can be marketed.
The De Novo process is a new regulatory pathway that was established under the 21st Century Cures Act. The De Novo process provides a pathway for low-to-moderate-risk novel devices that do not have a legally marketed device that is substantially equivalent to serve as a predicate.
Pre-market notification or 501(k) program:
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Submitters must compare their devices to one or more similar legally marketed devices and make and support their substantial equivalence claims.
This is the most commonly required submission out of all the regulatory requirements.
The Premarket Approval (PMA) review calls for a thorough investigation of a medical device to demonstrate its efficacy and safety through the creation of a data-driven benefit/risk profile. Clinical trials and a significant amount of time and money are typically required for the PMA process in order to collect enough data. During this time, the FDA will also conduct a thorough review of your quality system.
Establishment Registration and Medical Device Listing:
This is a requirement for all finished device manufacturers and medical device importers into the US. When manufacturers plan to market their medical devices, they must register those devices with the FDA. Manufacturers outside the US are also required to register their products and appoint a US agent to represent their foreign business.
Medical device labeling:
This relates to the labels on the equipment. It establishes guidelines for the use , advertising or promotional content that is printed on the label. While being marketed, the labeling cannot be deceptive or false. This will lead to misbranding , and that is against the Federal Food, Drug, and Cosmetic Act. This guarantees to the FDA during clearance or approval, that the medical device is manufactured in accordance with the specifications.
Quality systems regulations
This is the FDA’s current method of good manufacturing practices. It details every legal requirement related to buying, designing, making, packaging, labeling, storing, setting up, and maintaining the devices. These requirements must be followed by all manufacturers.
Medical device reporting:
The FDA has this system in place for reporting any negative events involving a medical device. A device malfunction that results in harm or death could count as an adverse event. Device importers, manufacturers, and user facilities are all required to report any instances of a negative event. This aids in keeping an eye on the device’s security and delivering prompt interventions and corrections to stop any hazards.
Investigational device exemption (IDE):
Under this program, the FDA requires unapproved medical devices to be approved for clinical studies on human subjects for safety and efficacy purposes. If the device carries a high risk, the FDA and an institutional review board must both approve it (IRB). If the device poses no significant risk, the IRB’s approval is all that is required.
FDA Medical Devices Classification & how to get them in market:
Although the FDA classifies more than 1700 medical devices in the Code of Federal Regulations (CFR) according to 16 specialties, such as cardiovascular or hematology devices, the complexity of regulatory processes regarding FDA approval and bringing a new device into the US market depends on the new device’s risk, invasiveness, and impact on the patient’s overall health, dividing all the medical devices into 3 main classes:
FDA approval process for Class I Medical Devices
According to the FDA, devices classified as Class 1 Medical Devices are those that are “not intended to be used in sustaining life or of substantial importance in preventing impairment to human health, and they may not pose an unjustifiable risk of disease or injury”.They are the most low-risk medical devices. There are about 780 such devices from bandages and wheelchairs to electric toothbrushes and tongue depressors.
As they do not come into contact with the patient’s central nervous system, cardiovascular system or any internal organ, they are subject to the fewest regulations. The majority of Class I devices are exempt from FDA requirements for Premarket Notification (510k) and Premarket Approval (PMA), but they are not exempt from FDA general controls, a series of commands which applies to all medical devices. Although easiest to bring to the market, class 1 devices are still required to implement a quality management system and follow standards to ensure a quality product.
FDA approval process for Class II Medical Devices
The FDA defines Class II Medical Devices as “devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.” They are medium to moderate risk devices. There are about 800 such medical devices, including pregnancy test kits, syringes, contact lenses and surgical gloves.
As they are more likely to come into prolonged contact with the patient, they are considered more riskier than class 1 devices and subject to stricter regulations. Almost all of class 2 devices are FDA approved for the market through the Premarket Notification, or 510(k) process. As stated above, this procedure entails demonstrating “substantial equivalence” to an already existing & approved device, also referred to as “the predicate” in FDA terminology. The devices must share a great deal of usage, design, material, labeling, standards, and other characteristics—not that they must be identical.
Note: Since early 2018, a number of class 1 and 2 devices have been exempted from the 510k process by the FDA, you can find them in the FDA Product Classification database.
FDA approval process for Class III Medical Devices
The FDA defines Class III Medical Devices as products which “usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury.” They are of high risk, generally life supporting and life-sustaining devices. There are about 120 of them and are the ones most thoroughly examined by the FDA. Breast implants, Pacemakers and ventilators are some devices that fall into class 3.
Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. The manufacturer has to follow these nonetheless. But the most intensive examination happens during the Premarket Approval (PMA) process. All class 3 medical devices are subject to the PMA process.
Clinical studies and a large amount of time and money are typically required for the PMA procedure in order to obtain enough data. The FDA also conducts a thorough review of the manufacturer’s quality system.
Note:The only exceptions to the PMA process for the Class 3 devices are the devices with an already FDA approved equivalent. One can determine if a device falling in class 3 can be marketed with a 510(k) alone without a PMA by checking the FDA’s Premarket Approval (PMA) database and the 510(k) Premarket Notification database.
In conclusion, not all medical devices require FDA approval before they can be marketed and sold. The FDA regulates medical devices based on their level of risk, with higher-risk devices requiring more regulatory oversight than lower-risk devices. Medical device manufacturers can obtain approval or clearance for their devices through several regulatory pathways, including the premarket approval process, the premarket notification process, and the De Novo process. It is important for patients and healthcare providers to understand the level of regulatory oversight that applies to a particular medical device and to use medical devices in accordance with their intended use, indications for use, and any relevant warnings, precautions, and contraindications.In summary, it can be said that whether your Medical device needs an FDA approval and which regulatory pathway it has to take to get one depends on the device class. its intended use,risk associated with the consumer and the latest FDA regulations it is subject to. Getting all of this right might be very confusing for businesses trying to get their product in the market quickly. RegDesk can help them in doing so.
How Can RegDesk Help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.