Understanding FDA Regulations for Electronic Medical Devices

FDA regulations for electronic medical devices are a complex web of ever-changing rules and restrictions that can confuse even experienced OEMs! However, failing to comply with the agency might result in expensive penalties that your company can't afford. 

So, you should know what you can and can't do when manufacturing, testing, and distributing these products. While it would be impossible to list every FDA regulation in this article, you'll learn the most important rules below, which can help you stay on the right side of the law. For true medical device compliance, consider working with a medical device contract manufacturer that can help you navigate the FDA regulations.

What You Should Know About FDA Regulations for Electronic Medical Devices

The FDA, or its subagency, the Center for Devices and Radiological Health (CDRH), regulates companies that manufacture electronic medical devices like yours. It categorizes medical devices into three categories:

1. Class I (low to moderate-risk medical devices)
2. Class II (moderate to high-risk medical devices)
3. Class III (high-risk medical devices)

Regulatory controls increase as each device class increases.

All devices require general controls, as the Federal Food, Drug, and Cosmetic Act (FD&C Act) outlines. These provisions relate to misbranding products, correctly registering products, and keeping accurate reports during the medical manufacturing process.

However, most Class II devices also require special controls, which include performance standards, special labeling requirements, and post-market surveillance.

Finally, Class II devices normally require a Premarket Approval Application (PMA) and general controls. The FDA reviews these documents to evaluate a medical device's safety and effectiveness before approval. You'll learn more about this later.

Premarket Notification

If you want to market an electronic medical device in the U.S. for human use, you must submit a premarket notification, also known as a 510(k), to the FDA unless:

• Your device requires a PMA (normally because it's a Class III device)
• Your device is otherwise exempt from 510(k) requirements

Most Class I and some Class II devices fall under the latter. These include cardiovascular, dental, anesthesiology, and neurological devices. You can see a full list of what's exempt here.

If your device isn't exempt, you must follow the 510(k) requirements. You must demonstrate to the FDA that your device is safe and effective, meaning it's equivalent to a "legally marketed device" already in distribution.

The FDA defines legally marketed devices as those that:

• Were legally marketed before May 28, 1976
• Reclassified from Class III to Class II or I
• The FDA found to be substantially equivalent to a legally marketed device through the 501(k) process
• Were granted marketing authorization via the De Novo classification process
• Are not otherwise exempt from premarket notification requirements

As you can see, the premarket notification process can be complicated, especially if you've never gone through it before. That's why you might want to use a medical device contract manufacturer. Choose one that can help you avoid regulatory headaches and oversee any compliance issues that might arise with your product.

Quality System Regulation

Quality System Regulation (QSR), or FDA 21 CFR Part 820, ensures medical devices meet current good manufacturing practices (CGMP)— a complex set of quality and safety standards. These rules will change somewhat in 2026, but you must establish and follow an in-house quality management system to comply with the FDA's requirements.

You might create a quality management system that includes:

• Implementing supply chain practices that support quality
• Checking devices meet user needs
• Assembling a quality assurance and compliance team
• Identifying devices or device components that might be unsafe or cause injury
• Carrying out regular safety checks and inspections

This is just the tip of the iceberg. QSR includes 15 subparts that cover design, manufacture, labeling, packaging, and other components. You'll need to interpret these rules the best you can and apply them to your device, which might be complicated.

Premarket Approval Application

As mentioned earlier, Class III electronic medical devices normally require a Premarket Approval Application (PMA). OEMs that fail to meet PMA requirements can't market their devices.

Here's where things get complicated again. PMA requirements are different depending on the device you're trying to market. For example, specific rules for "pre-amendment devices" have been in commercial distribution since before May 28, 1986, and now need FDA approval.

Whether your device is brand new or already in circulation, you must come to grips with the PMA process. This involves creating a detailed document that might include information about:

• Your manufacturing and quality assurance protocols
• How you designed your device
• Whether your device carries any safety risks

You'll then send your application to the FDA for review.

Next Steps to Take for Medical Device Compliance

Understanding the FDA's ever-complicated rules and regulations for electronic medical devices is tough. However, you must comply with the agency to avoid penalties and preserve your reputation.

Whether you need to submit a PA, undergo the premarket notification process, or establish a quality system, Sanbor Medical is here to help! Our personnel can help guide your product to regulatory approval. Contact us today to learn more!