FDA Medical Device Classes and Approval Routes

15 Jul 2024

The US Food and Drug Administration has established rigorous screening processes for the medical devices involved in sustaining or supporting a human life. For approximately 1,700 different types of devices, the FDA has created medical device classes. These classes are divided into 16 distinctive risk categories, and each category is given the classification of Class I, Class II, or Class III, depending on the regulations that apply. The classification system serves the straightforward goals of expediting the time to market for devices whose intended use and indications for use make them intrinsically safer and ensuring that adequate safety measures are given to devices that entail greater risk.

To identify the regulation number that corresponds to the classification regulation for your device to ascertain its classification and any potential exemptions. There are two ways to do this: either go straight to the classification database and search for a specific part of the device name, or if you are aware of the medical specialty (device panel) that your device is a part of, go directly to that panel’s listing and find your device along with the regulation that goes with it.

To avoid this confusion, Food and Drug Administration classifies medical devices being manufactured and marketed in the USA into three main categories:

• Class I medical devices
• Class II medical devices
• Class III medical devices

The major attributes on which these devices are classified include their invasive properties, risk profile and impact on patient’s health. Moreover, the path to place these devices in the market also differ.

Let’s have a look at each of these class of medical devices one-by-one:

Class I Medical Devices (low to moderate risk): General Controls

Class I medical devices are the ones with the lowest risk and hence, are subjected to least regulatory requirements.Under FDA, these devices are defined as:

“not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.”

Class I medical devices are the least invasive, have minimal contact with the patients, and do not impact patients’ health hugely. These devices do not come in contact with cardiovascular system, central nervous system, or any other internal organ system of the patient’s body.

Common examples of Class I medical devices include:

• Tongue depressor
• Oxygen mask
• Bandages
• Reusable surgical scalpel
• Electric toothbrush
• Non-electric wheelchair
• Hospital beds

It is very easy to place Class I medical devices in the market, since they pose the least risk to the patients and are subjected to general controls (General controls apply to all medical devices, unless exempted by regulations. If a device is exempted from one of the general controls, such exemption is stated in the classification regulation for that device). Most Class I devices are not required to submit a premarket notification.

However, it is important to mention that these devices still must abide by FDA General Controls. Class I medical device manufacturers should also implement a QMS (Quality Management System) based on Quality System Regulation to ensure quality in their products.

Class II Medical Devices (moderate to high risk): General Controls and Special Controls

Compared to Class I medical devices, Class II medical devices are complicated. Since they are likely to make a sustained contact with the patient, the risks associated with them are higher.

The FDA definition of Class II medical devices is:

“edevices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.”

Common examples of Class II medical devices are catheters, contact lenses, blood pressure cuffs, syringes, pregnancy test kits, blood transfusion kits, and absorbable sutures, etc.

How to Place a Class II Medical Device in the Market?

Along with FDA General Controls, Class II medical devices are also subjected to Special Controls. Special controls can include special labeling requirements, performance standards, and special registries. Other examples of controls imposed on Class II medical devices can include:

• Patient strategies
• Guidelines
• Device performance
• Post-market surveillance
• Special labeling requirements
• Premarket notification requirements (also known as 510(k) submission)

Premarket Notification 510(k) Process for Class II Medical Devices

Most of the Class II medical devices must use the premarket notification 510(k) process before reaching the market. The 510(k) demonstrates safety and effectiveness of a device by showing that the device in consideration is equivalent to another device already placed on the market (the predicate device).

The device in question must show a substantial equivalence to the predicate device. However, this doesn’t imply that the manufacturers have to make their device completely identical to the predicate device. Instead, such devices should be significantly similar in design, labeling, materials, use, standard, and other characteristics of the predicate device.

Class III Medical Devices (high risk): General Controls and Premarket Approval (PMA)

Class III medical devices are the most heavily regulated ones. According to FDA, Class III medical devices

“usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury.”

Class III medical devices include permanent implants, life support systems, and smart medical devices. Their examples include:

• Defibrillators
• Breast implants
• Cochlear implants
• Fetal blood sampling monitors
• Pacemakers
• Implanted prosthetics
• High-frequency ventilators

How to Bring Class III Medical Devices to the Market?

According to FDA, utilizing only general and special controls is insufficient to ensure safety and effectiveness of Class III medical devices. Therefore, it requires additional pathway, the PMA (Premarket Approval).

The PMA process comprises four steps:

Step 1: Acceptance and Filing Reviews – An administrative or limited scientific review performed by FDA staff to determine completeness.

Step 2: Substantive Review – An in-depth regulatory, scientific, and Quality System Review is performed by the FDA personnel having the relevant expertise.

Step 3: Panel Review – Review and recommendations are presented from the advisory committee.

Step 4: In the last step, final deliberations and documentation take place with FDA issuing the notification.

Throughout these steps, various clinical trials are performed, with a lot of time and resources being invested in data collection. A substantive review of the medical device manufacturer’s quality system is also performed.

The De Novo Pathway

The De Novo pathway is yet another regulatory pathway set forth by FDA for novel, low-to-moderate-risk devices. De Novo pathway is separate from 501(K), as there is no need for a predicate medical device. However, in terms of safety and efficacy, this pathway is more complicated then 501(k).

Let’s see how it works:

• In 501(k), a predicate device is already present on the market. This leads to the assumption that the device is already safe and effective.
• In De Novo Classification, manufacturers have to work from the beginning to prove safety and efficacy of their medical device.

Whatever the case is, the De Novo Pathway is considered to be more competitive by some device makers. By the time a De Novo request is granted, FDA has already made a decision on basis of the submission made by the manufacturer. In essence, De Novo pathway provides manufacturers a chance to classify their device as either Class I or Class II. Additionally, manufacturers can also argument to place their device from one class into another.

How to Know the Best Pathway for Your Medical Device?

Placing a medical device in the US market can be challenging. As a medical device manufacturer, you must fulfil all the necessary obligations of FDA, determine the class of your medical device, and select the appropriate pathway as well. At TS Quality and Engineering, our expert consultants are ready to take care of all the hassles, providing you with the best consultancy experience in FDA regulations. Inquire us and learn more about our services today!