Step 1: FDA Device Classifications

During the approval process, the FDA classifies a medical device based on the risks the device poses to patients. How the device moves through the FDA approval process depends on the classification. These classifications are:

Class 1: General Controls

The FDA considers Class 1 devices as posing the least amount of risk. Low-risk devices include products like oxygen masks or surgical tools. These devices follow “general controls” for approval. General controls include consideration of the following factors:

  • Good manufacturing practices
  • Reporting adverse events to the FDA
  • Registration
  • Meeting general recordkeeping requirements

General controls are designed to ensure safety and effectiveness of devices after they are manufactured.  

Class 2: General Controls and Special Controls

Class 2 devices present more risk to consumers than Class 1 devices. For this reason, the FDA has special controls for the approval process, in addition to general controls. These special controls include:

  • Labeling requirements (includes information that the manufacturer must include on the product label)
  • Device-specific mandatory performance standards
  • Device-specific testing requirements

These special controls are in addition to general controls, and therefore both categories apply.

Class 3: General Controls and Premarket Approval

Class 3 devices are generally those that are designed to be implanted into the body, provide life support or have an “unreasonable” risk of injury or illness. Examples of these devices include certain diagnostic tests, breast implants and pacemakers. Class 3 devices require premarket approval because of these risks. Manufacturers must prove that their device is safe and effective in order to gain approval. Class 3 devices are also subject to general controls.

Step 2: FDA Approval Process

Once a medical device has been classified, researchers can begin preclinical studies. Generally, a device prototype is created, and is tested in a controlled laboratory setting. This process helps researchers refine the device and its potential impact on humans.

Step 3: Pathway to Approval

The “pathway to approval” for medical devices depends on the risk classification. There are several potential pathways, which include the following:

  • Class 1 – Most often exempt from premarket submission.
  • Class 2 – 510(k) premarket notification. A 510(k) status requires proof that the medical device is “substantially equivalent” to a legally marketed device not subject to premarket approval (PMA). Requires special controls (performance standards, patient registries, postmarket surveillance).
  • Class 3 – Premarket application (PMA).
  • “De Novo”  – Types of medical devices that have not been marketed in the U.S., but the technology and safety are “reasonably well understood”
  • Humanitarian Device Exemption (HDE) – Devices intended to benefit patients suffering from “orphan diseases”, or those affected less than 4,000 patients each year in the U.S.

Depending on the class and nature of the medical device, the pathway may include one or more of these processes.

Step 4: FDA Device Review

Once a medical device developer determines that the device is safe and effective, they can file an application with the FDA to market the device to consumers. Once an application is filed, the FDA has the opportunity to review the device and application before issuing a decision.

Like other steps in the process, the application process depends on how the device is classified. For example:

  • Humanitarian Device Exemption (HDE) – Before an HDE can be approved for marketing, the developers must demonstrate that there are currently no similar, legally-approved devices available in U.S. markets, and that there is no other way to bring such a device to the market.
  • Premarket Notification 510(k) – This notification indicates that a medical device is similar to others currently on the market. The developer supports the claim by comparing their device to others legally marketed.
  • Premarket Approval Application for Class 3 Devices – Applications for Class 3 devices must include data from all clinical and nonclinical studies. The FDA will inspect all manufacturing facilities and laboratories during the approval process to ensure good manufacturing practices.

The FDA has the ability to schedule a public meeting where they consult with an Advisory Committee about the device. The Advisory Committee is made up of experts who advise the FDA about the medical device, its safety and effectiveness, and whether they believe the product should be approved or not.

Step 5: FDA Post-Market Device Safety Monitoring

Once a medical device has been approved, it can be marketed for consumer use. However, the approval process essentially continues in the form of monitoring. The FDA continues monitoring approved medical devices for safety and effectiveness. At any time, the FDA can initiate a recall, can impose penalties on non-compliant facilities, or can reverse approval if serious issues arise.

The FDA is strongly focused on reporting and monitoring medical devices, which is why it established the MedWatch Adverse Event Reporting Program, as well as MedSun, the Medical Product Safety Network. These programs allow healthcare providers and consumers to report side effects, adverse events, or defects in medical devices.

Recognizing problems with safety or effectiveness, and taking action quickly are important to preserving consumer safety.

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