How the Design Control Process Applies to a 510(k) Premarket Notification

At its core, the 510(k) Premarket Notification pathway comes down to assuring regulators that your medical device is safe and effective.For many medical device companies, what constitutes “safe and effective” can cause undue confusion. But the question of how to prove these rather-broad sets of criteria can actually be answered by following one process: design controls.

Design controls are the most effective form of documented, objective proof that you have designed a safe product that meets user needs and regulatory requirements. During this process you will define design inputs and design outputs, establish standards for quality, incorporate a risk-based approach, and connect every component of the device back to end users. 

Keep reading to learn how design controls connect to your 510(k) by understanding the different sections of a 510(k) submission and when and where your design controls fit into the process.

FREE RESOURCE: Click here to download your free PDF copy of our design control & DHF table for 510(k) submissions.

Is it possible to draft a 510(k) submission without a design control process?

Throughout my career, I have believed the answer to that question to be an emphatic “no”. However, more recently, I have come across many, many examples of companies and individuals who have submitted 510(k)s and documented no design controls.

It blows my mind that somebody would consider submitting a 510(k) without having design controls documented in a design history file.

Why? To me, there is no way to construct a 510(k) submission without design controls.

Whenever I have worked on completing a 510(k) submission, I start first by establishing the design controls and DHF. I actually use the contents of a DHF to guide the preparation of a 510(k) submission. In fact, documenting and organizing design controls in a DHF should be the first step taken in preparing a 510(k) submission.

Once you get FDA 510(k) market clearance, you will be subject to inspection by FDA. It may not happen immediately after getting clearance. However, you should anticipate that an inspection will happen since FDA has a mandate to do so at least every two years for medical device companies with Class II and Class III products.

And year after year, design controls are cited as a top issue during FDA inspections.

Doesn’t it make logical sense to ensure and establish that design controls are captured and documented before you actually submit that 510(k)?

Understanding the role of your design control process in a 510(k) submission

A successful 510(k) submission process rests on these following two pillars:

• Demonstrating a device to be substantially equivalent to a predicate device
• Establishing a thorough risk mitigation plan

Design controls play a massive role in both of these requirements. By focusing on design controls in your 510(k) submission, you’ll be able to easily compile the necessary documentation and assets needed to demonstrate substantial equivalence to predicate devices and the foundation of a thorough risk management plan.

Let’s zoom in on both sides of the proverbial 510(k) submission coin to see how design controls can bolster your claims for substantial equivalence and a competent risk mitigation strategy.

How do design controls help with demonstrating substantial equivalence?

Demonstrating substantial equivalence to a predicate device establishes a standard to which a device can be compared. 

This is extremely helpful to both manufacturers and FDA officials alike; medical device companies can use them during product validation and verification, and FDA investigators can easily understand a device’s potential at a glance. 

While the FDA view of predicate devices is somewhat vague, they do provide a valuable piece of guidance on substantial equivalence. In this guidance document, the agency recommends that medical device manufacturers choose a predicate device that is most similar with regard to intended use and technological characteristics.

Establishing a device’s intended use and indications of use is quite literally a part of the design control process. These definitions help to determine key factors like: 

• User needs have been met

• Human and environmental factors have been considered

• All user groups have been identified

• Validation you’ve built the right product

• Verification you’ve built the product right

Additionally, separate FDA guidance points to another application of design controls, specifically the labeling and packaging steps required for 510(k) submissions. 

Section 513(i)(1)(E) of the Act generally limits the determination of the intended use of a device that is the subject of a premarket notification (510(k)) to the proposed labeling contained in the submission.

When they refer to labeling, this includes:

• Labels that are affixed to the device, 

• Labels on packaging, 

• Any inserts within the packaging 

• Any advertising or promotional materials such as your website. 

FDA will evaluate all labeling to determine the intended use of the medical device and additionally, whether it is substantially equivalent to a predicate device.

How does the design control process connect to risk mitigation?

Design controls are intended to demonstrate that a medical device has been:

• Designed to address the needs of users and patients.

• Designed to meet inputs and requirements.

• Proven to meet applicable standards.

• Meets performance criteria.

If you are thorough with defining and documenting user needs, design inputs, design outputs, design verification, design validation, and design reviews, then you will be on the right track towards ensuring your medical device is safe.

Connect your design control process to every part of your product with Greenlight Guru

510(k) submissions need documentation of the design control processes in order to be successful. So, wouldn’t it make sense to dedicate the same due diligence throughout the entirety of your medical device’s lifecycle? 

With Greenlight Guru’s dedicated Design Control Software, you can easily achieve 21 CFR Part 820.30 and ISO 13485 compliance with an auto-generating, auto-updating DHF. Our end-to-end platform eliminates data silos, so you can create and update your traceability matrices and schedule a design review in mere minutes — not hours or days. More than that, our solution ensures full visibility and connectivity between your inputs, outputs, verifications, and validations related design inputs, risk controls, and components.

Want to see it in action? Contact us today to get a deep dive into our Design Control Software, ask questions, and see your multi-level design control matrix come to life.