Why Class 1 Medical Device Companies Need Design Control

Even if it’s not required, it’s critical

Published: Wednesday, September 14, 2022 - 12:03

I know what you’re thinking. You’ve got a medical device prototype that the FDA has categorized as Class I. You’re ready to push forward to manufacturing or marketing the device, since there are no formal requirements for design controls. “So why would I waste time on design controls?”

The fact is that, regardless of regulatory requirements, design controls are massively important to developing safer devices that fulfill user needs and improve the quality of life.

Don’t believe me? Here are three reasons you still should perform design controls, even if they aren’t required for compliance.

Factoring in exceptions to FDA design-control exemptions

The FDA mandates design controls in its quality system regulation (QSR) 21 CFR Part 820.30 as part of its current good manufacturing processes (cGMP). The regulation also states that design controls are required for all Class II and Class III devices, and requires manufacturers to establish, maintain, and document procedures for design controls.

In general, Class I devices aren’t required to implement design controls. In fact, 95 percent of Class I medical devices are exempt from anything above general controls. This is because the FDA has determined that this class of devices poses a low risk to users and patients.

However, even with exemptions, there’s always an exception to the rule. 21 CFR Part 820.30 also outlines several Class I device types that still require design controls, such as:
• Surgeons’ gloves
• Protective restraints
• Tracheobronchial suction catheter
• Manual radionuclide applicator system
• Radionuclide teletherapy source

From a risk perspective, it makes sense that these products would require design controls. For example, surgeons’ gloves routinely have contact with internal organs, and radionuclide teletherapy is an important part of life-saving cancer treatments. 

It’s also clear that the requirements in CFR 820.30 are written with future user needs in mind because the regulation includes a clause that requires design controls for any Class I devices automated with computer software. With Software as a Medical Device (SaMD) regulations constantly evolving, it’s important to consider that devices categorized as Class I today may end up being Class II tomorrow.

The takeaway here is that a sound design control process prepares you for what’s to come, helping you mitigate risk for any customer complaints that may occur during the postmarket phase of the product life cycle. Just because a device is technically exempt from design controls doesn’t mean you’re exempt from designing products to improve quality of life.

Avoiding design controls limits your device’s potential

At first glance, having a Class I device may seem like an ideal scenario. With minimum requirements for regulatory oversight, manufacturers of low-risk devices can push products to market faster. And why shouldn’t they? In the eyes of the law, these are products that pose minimal risk to patients and have next-to-zero effect on overall quality of life.

But does low risk mean low reward? True, the Class I distinction may provide fewer hurdles—but it also significantly restricts how a device can be used. Now, there’s nothing wrong with tongue depressors, and doctors will always need stethoscopes. But when manufacturers choose the Class I designation as part of its regulatory strategy purely for the lack of design controls, it can hinder a device’s potential.

This also affects the business side of medical devices. Class I requirements limit the scope for a device’s intended use and indications for use, including any claims made in marketing materials.

A good example of this is the wellness apps market, where fitness trackers and meditation apps make general health-related claims rather than references to a specific disease or condition. For instance, a Class I fitness tracker can claim to promote weight loss, but it can’t be used to treat type II diabetes.

However, that all changed in 2018 when the Apple Watch 4 became a Class II medical device. After implementing design controls, which are required for a 510(k) submission, Apple gained a significant advantage over wearable technology competitors like FitBit because they were able to develop and market new features for EKG heart-rate monitoring and fall detection to the general public.

Design controls make for better product development

With so much focus on how design controls are regulated, it’s easy to lose focus on the why. Think about the definition of medical devices, which are products used in the “diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man.”

Your product affects real people, whether they’re patients, providers, or other beneficiaries. So the processes you use to design and manufacture your device must be safe, effective, and managed with the utmost care. Even if a device is categorized as Class I, it must be ideated, designed, tested, and manufactured based on the people who actually use it.

Design controls matter because they provide critical proof that the device you’ve designed is safe and meets user needs and requirements.

This is the reason why the FDA emphasizes design controls. It’s why ISO 13485 includes them as one of four components of a quality management system (QMS). It’s why they’re so intricately connected to risk management standards such as ISO 14971. And it’s why traceability and documentation are an absolute must to demonstrate how all these processes are linked.

Regardless of whether your device has regulatory requirements for design control procedures, using them in your product development life cycle will mitigate risk and ultimately lead to safer medical devices that improve the quality of life for end users.

And, try as I might, it’s hard for me to imagine a better reason than that.

First published August 12, 2022, on Greenlight Guru.

About The Author

Etienne Nichols

Etienne Nichols is a medical device guru and mechanical engineer who loves learning and teaching how systems work together. With a Project Management Professional (PMP) certification, Nichols is experienced in manufacturing and product development aiding in the development of combination drug-delivery devices.