The Arduous Path of Getting Medical Devices Approved: Why Medical Devices Are Strictly Regulated?

Medical devices, though beneficial to mankind, also have the potential to cause harm. As such, they are strictly regulated. This article covers important aspects of why and how these medical devices are approved by the FDA before they make their entry into the market.

Medical Devices Are Regulated by the Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is a government agency that regulates medical devices. It is part of the Department of Health and Human Services, which also includes the Centers for Disease Control (CDC) and the National Institutes of Health (NIH). 

The FDA’s mission is to protect public health by ensuring that drugs are safe and effective. It also ensures that human food and animal feed are safe, promotes competition in the bio-pharmaceutical industry, and develops ways to improve product labeling practices. 

Tracking new drugs through clinical trials before they’re given approval for sale in pharmacies across America is also one of the major areas where the FDA functions.

As you can see from this brief introduction, there are many functions performed by one organization. But don’t worry. We will go into much more detail later on when we discuss what types of medical devices need approval before they are sold commercially.

The FDA Regulates Medical Devices to Ensure They’re Safe and Effective for Their Intended Use

It is important that medical devices are designed in a clean setting with zero contamination. And cleanrooms provide that special environment that is free of contamination-causing airborne particles. 

Therefore, the FDA maintains existing standards related to cleanrooms for medical devices as well as a comprehensive list of ISO Standards and guides relating to cleanrooms. The agency maintains these regulations in order to ensure that the medical devices are safe and effective for their intended use.

These include ISO 14644 Standards and the more specific ISO 14698:2003 Guide to Clean Rooms and Associated Controlled Environments, which define criteria for classifications of cleanrooms based on the types of particles they can exclude from the air. 

The standard also provides detailed information on how these classifications were determined through testing programs conducted by various organizations around the world.

Classification of Medical Devices in Class I, II, and III

In order for a medical device to be approved by the FDA, it needs to be classified into one of three classes based on its level of risk: Class I, II, and III.

Class I devices are low-risk. These include items like bandages and tongue depressors. Because they’re so low-risk, there’s no need for premarket approval from the FDA in order to sell them.

Class II devices are at moderate risk. Items in this category include blood pressure cuffs and surgical sutures that have been deemed safe but require oversight by a medical practitioner before use, and only licensed doctors can prescribe them. 

Some class II devices are also regulated as class III devices if they contain radioactive material or other components that are dangerous if mishandled during use or disposed of after use.

Class III devices pose an especially high level of risk. This is because they involve invasive treatment or procedures such as pacemakers or implantable defibrillators. These kinds of things require premarket approval from the FDA in order to ensure their safety and efficacy before being sold commercially.

Medical Device Manufacturers Must Submit Premarket Approval (PMA) Applications

PMA is a process that allows manufacturers to sell a device that hasn’t been previously approved by the FDA. But before they can submit an application, they must first determine whether or not they need one based on the type of device being developed. If it’s a new type of product, then PMA is required.

The manufacturer must prove that their device is safe and effective for its intended use as determined by placing it into one of three categories. While most devices fall into Class I, which means there are no restrictions on their sale or use, most Class II and Class III devices require premarket approval from FDA prior to being marketed.

The FDA Requires 510(K) Premarket Notification Submissions 

Manufacturers who want to start selling a product that’s similar to another legally marketed medical device must file a 510(k). These submissions are not required for certain devices in Class I and II category. 

A 510(k) submission has two major parts: (1) an extensive description of how the new device compares with its predicate, and (2) supporting data on how it performs. When submitting this information, manufacturers should provide the most rigorous evidence they have demonstrating their product’s safety and effectiveness through well-controlled studies.

Manufacturers Seeking PMA for Their Products Must Ensure Their Manufacturing Facility Meets the Regulatory Standards of the FDA

Manufacturers must take all reasonable steps to ensure their manufacturing facility meets the regulatory requirements set by the FDA. This can be done through documentation or other means, such as tests and inspections of cleanroom classes and standards for medical devices.

The FDA has issued guidance documents on cleaning, disinfection, and sterilization processes in accordance with 21 CFR 820 – Quality System Regulation. The guidance describes how a manufacturer should follow its own procedures to achieve good manufacturing practices GMPs.


The path to getting medical devices approved is a long one. It can take up to nine years for a device to be approved, and there are many reasons for this. The main reason is that these types of devices have the ability to hurt people if they aren’t properly tested or regulated. 

That’s why there are strict regulations on what can go into our bodies. And this article has covered some of the reasons why medical devices are so heavily regulated.


Don't Miss IT