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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.
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)?
A successful 510(k) submission process rests on these following two pillars:
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.
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.
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.
The best practices of medical device product development have a good flow between design controls and risk management. For example, as you identify hazards and hazardous situations, these should “feed” into the design controls process in defining user needs and design inputs.
Prior to clinical use, you have to know without a doubt that the product is safe and/or determine that the medical benefits outweigh the risks, which should be documented in a benefit/risk analysis.
At least fourteen of the twenty sections of FDA’s 510(k) submission requirements relate to your design controls. Below, I will explain the specific sections of a 510(k) submission that incorporate design controls.
FDA describes the indications for use statement as:
The statement should include specific indications, clinical settings, define the target population, anatomical sites, etc. This statement must be consistent with your labeling, advertising and instructions for use.
Your indications for use describe the entire purpose for your medical device. This statement then feeds into establishing user needs for your product.
Furthermore, user needs initiate the design control process. User needs are the primary basis for establishing your design inputs. Towards the end of your development efforts, user needs also play a significant role. Design validation demonstrates the product you have developed meets the user's needs.
The 510(k) summary is an overview of your medical device. The 510(k) summary includes:
A description of the device according to the product labeling (relates to design outputs)
Explanation of how the device functions (relates to design inputs)
Physical and performance characteristics including device design, materials, and physical properties (relates to design inputs)
Predicate device comparison via technological characteristics and testing (relates to design inputs, design outputs, and design verification)
Summary of nonclinical testing (or clinical testing, if applicable) (relates to design verification)
These items are a combination of design inputs, design outputs, and design verification activities.
In this section, FDA outlines its requirements for manufacturers to provide declarations of conformity to any standards followed. For some device types, there may be applicable performance standards to follow during the product development process, such as IEC 60601-1 and ISO 10993. Criteria contained within standards, such as these, often relates to design inputs as well as design verification.
The executive summary section comprises a culmination of indications for use (section 4.0), device description (§ 11.0), device comparison (§ 12.0), and performance testing (§ 18.0, § 19.0, and § 20.0). There are elements of user needs, design inputs, design outputs, design verification, and design validation included in the executive summary.
The section for device description includes details relating to your design inputs and design outputs. Section 11.0 can often be fairly detailed and include drawings and schematics to help explain your product in your 510(k) submission to FDA.
In this section, you are comparing your medical device to the predicate product. This substantial equivalence discussion will primarily focus on specific product characteristics (design outputs) and side by side comparison, often in the form of testing (design verification).
Proposed labeling includes the labels included on your product and packaging, as well as instructions for use and operator manuals. Labeling should be described and captured as design outputs.
Design inputs should describe sterilization methods, identify specific sterilization parameters, describe packaging criteria, and shelf life. Your design verification activities must be able to demonstrate these inputs have been met. This will include sterilization validation and shelf life testing.
Biocompatibility closely relates to design inputs and design verification, as your design inputs must describe type of body contact and duration. Additionally, design verification must demonstrate the materials are safe and effective and meet the established biocompatibility design inputs.
If your device contains software, this section of your 510(k) submission will contain software-related design inputs, design outputs, and design verification activities.
Be prepared to follow the FDA guidance on Content of Premarket Submissions for Software Contained in Medical Devices and provide documentation described within this document.
If your medical device has electronic components, this section must contain evidence to support electrical safety. This relates to design inputs, design outputs, and design verification.
I suggest familiarizing yourself with the industry IEC standards for electrical safety to ensure you are designing for compliance with IEC 60601 in order to avoid any hiccups during the 510(k) submission review process.
Any “bench” testing conducted as part of product development efforts must be summarized in this section of your 510(k) submission. This relates to design verification activities.
Any “animal” testing conducted as part of product development efforts must be summarized in this section of your 510(k) submission. This often relates to design verification activities and sometimes design validation.
Any “clinical” testing conducted as part of product development efforts must be summarized in this section of your 510(k) submission. This often relates primarily to design validation.
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.
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...