Log in

FDA regulations for medical devices: Key insights for your product journey 


If you plan to launch a medical device in the United States, then you'll need approval from the FDA (The US Food and Drug Administration). US law requires testing high-risk devices before Premarket Approval and Premarket Evaluation of those that present a moderate risk. Their goal is to ensure that products are safe and effective before ending up in the hands of patients and other users. 

So if your goal is to take part in the $4.1 trillion US healthcare market, you'll need to start your product journey by understanding general FDA regulations for medical devices, classification, approval paths and how this will impact your connected medical device, DTx, telehealth or SaMD development strategy. 

FDA medical device classification

The FDA divides medical devices across three classes depending on the potential risk to consumers. Class I is the least risky and is thus subject to the lowest controls, while Class III the highest. Here’s a quick explanation of each class: 

  • Class I: minimal patient contact and low impact on health. These devices do not directly interact with a patient's central nervous or cardiovascular systems or internal organs. Examples include electric toothbrushes, non-electric wheelchairs, oxygen masks. 95% of these products are exempt from the regulatory process but still require controls and general best practices. 
  • Class II: More complex and higher-risk products because they are more likely to involve sustained patient contact, including cardiovascular systems and internal organs. Diagnostic tools, especially those supported with AI and SaMD, are also often in this class. Blood pressure monitors, glucose strips, CT scanners are all examples. Products in this category are subject to Premarket notification and special controls. 
  • Class III: These products sustain or support life and may be implanted or present a high usage risk. 10% of US FDA-regulated products comprise this class and include smart medical devices and life support systems. Class III products are often the most cutting-edge, but some products may also be placed in the category if there is no equivalence to a predicate (existing) device on the market. Class III medical devices include pacemakers, SAMD that monitors severe conditions such as strokes and implantable cochlear stimulators. 

There is no exact strategy for what class a company should aim for. Your budget, experience and the HealthTech solutions partners you choose to work with help you understand the best course of action for you. 

What devices need FDA approval? 

This is where you need to pay careful attention to terminology. It's easy for outsiders to consider everything "FDA-approved" when in reality, there are many different ways to get your product to market depending on the risk it poses and the claims you want to make. 

Particularly important is understanding the difference between "FDA-approved" and "FDA-cleared." 

The process of Premarket Notification—510(k)—is for manufacturers submitting a device similar to one already on the market. In this process, you'll demonstrate how your product is novel from existing ones while also maintaining similar safety and efficacy levels. This will require documented lab testing though generally not clinical trials. Through this approach, you'll be able to market something as "FDA-cleared." 

How to get FDA approval for a medical device?

If you're bringing something totally new to the market or something that may create significant patient risk, you'll need Premarket approval (PMA). PMA is a longer, more complex process requiring extensive scientific laboratory evidence and clinical trial data to show your medical device is safe and effective. Completing this successfully will allow you to market as “FDA-approved.” 

Be aware that these are just two ways to get to market. For example, many DTx and digital healthcare companies have been going the De Novo route, which is for highly innovative products. If you're pursuing any SaMD, medical device software or other software-forward solution, this might be a good option for you. 

How long does it take the FDA to approve a medical device? 

Again this depends on the route you're taking. Class II devices generally require Premarket notification, which is much speedier than approval. For either Class II or Class III, it can take between a few weeks to over a year, with Class II devices typically falling on the lower end of the spectrum and Class III on the higher.  

But there is an immense amount of variability in this process. If you have collected all the necessary documentation and data you need, you can expect the approval process to go a lot quicker. Likewise, if you have made any mistakes during the design, build or any other stage, this will likely end up costing you more time and money. 

Go from medical device idea to groundbreaking product

FDA regulations for medical devices are immensely complex. This isn't even the tip of the iceberg. As you move through each stage of the process, additional challenges and opportunities will emerge along the way. 

At Star, our team of regulatory and product strategists, designers and engineers help our clients ideate, define, imagine, build, launch and maintain innovative, compliant and patient-centric medical devices that improve outcomes worldwide. Whether you're a startup, legacy player or cross-entrant looking to dip your toes in the world of connected healthcare, see how we can help you achieve your endgame. 

Star, Medical Device, FDA, Regulations, Tips, Business, Approval Process, US Food and Drug Administration, Classifications, Risks


No comments on this item Please log in to comment by clicking here