FDA Design Controls Explained

When conceptualizing the design for a new medical device, it is important to consider the FDA’s design control processes. Design control consists of a series of procedures and documentation requirements that are compiled to create the product’s submission for FDA approval. It is critical to understand these processes from the start to know which design control requirements apply to you, what your obligations are, and how to start organizing your documentation.

What Are FDA Design Controls?

The U.S. Food and Drug Administration has established strict controls and processes for developing medical devices to ensure consumers and patients are protected from the potential ill effects of poor design. Medical devices, especially, pose a potential risk for complications and side-effects over long-term exposure. However, because medical devices encompass a full spectrum of equipment, tools, and implants, the FDA has established an official procedural approach to the design of Class II and Class III medical devices. While these controls do not dictate specific practices, they do require stringent documentation to ensure the developer has accounted for patient or user safety and product efficacy.

The core principles behind the FDA’s design controls are quality assurance and good engineering principles, which form a manufacturing framework for organizations to follow as they conceptualize their product. 

Does My Product Need to Be Developed Under FDA Design Controls?

Not all devices are required to be developed under FDA design controls—even the medical devices that must adhere to these regulations are held to different requirements based on the risk they pose to users. A product’s risk level is determined by its intended use and its indications for use. Based on these factors, the FDA will designate products as Class I, Class II, or Class III. It is essential to know this information from design inception because they determine if your product must adhere to FDA design controls.

The three FDA classes are:

Class I: Low-Risk Products

Many Class I medical devices are exempt from the design control requirement. Also, nearly half of all medical devices fall under this low-risk classification because they are intended to promote general wellness and are not invasive. Some examples of common low-risk products include bandages, wellness apps, and bedpans.

Class II: Medium-Risk Products

These medium-risk products are also generally non-invasive and present limited risks to a patient or user. Common devices that fall under this class include x-ray machines, pregnancy tests, and surgical needles. Class II medical devices do require adherence to the FDA’s design controls.

Approximately 43% of devices are categorized as Class II.

Class III: High-Risk Products

This is the highest risk class a medical device can fall under, and all devices in this category are required to adhere to design controls. However, only 10% of devices are considered high-risk products. Items such as surgical systems and implantable devices are considered high risk.

FDA Design Control Core Components

Once you know your medical device is going to be subject to the FDA’s design controls requirement, it’s important to start accurately documenting your progress. All documentation should be compiled into a Design History File (DHF), which will act as the master file for all documentation regarding design controls. The FDA will need to have access to this file as they review your device. This file can also be audited throughout product development, so your team must keep it up to date and compliant with all requirements. 

These elements must be included in the DHF throughout the product design and documentation process:

• User Needs: This layer of documentation explains the needs of your intended market in relation to the product and how the product will satisfy those needs.
• Design & Development Planning: This is your plan for meeting design control requirements. It explains how the other parts of your documentation and design controls will be handled.
• Design Inputs: In this component, product developers detail the market specifications and product specifications. This includes research into market needs, the cost to the patients and users, and the product’s ability to meet the user’s or patient’s needs.
• Design Outputs: This documentation should record all of the components for the design, such as the schematics, any design drawings, required materials, and final specifications. They will be compared to the design inputs.
• Design Review: The design review component requires review from experts for each aspect of the product, including areas such as pneumatics, medicine, materials, and more.
• Design Verification: In this step, your organization needs to provide evidence that the device meets or exceeds product specifications and performs as planned. Developers can choose from multiple different types of analyses to verify this.
• Design Validation: The validation stage goes through market-specific requirements and regulations to ensure all legal requirements have been met. This examines both process validation and design validation. 
• Design Transfer: This transfer stage must thoroughly capture production specifications and clearly explain all the production steps, which are then transferred to the manufacturer to begin production. Careful documentation mitigates the risk of a manufacturer-caused design variation.
• Design Changes: All design changes must be controlled through change control and document control; that is, carefully documenting both mistakes and modifications, and thoroughly updating design files throughout the life cycle of the product.

Develop Your Product With Omnica

Omnica is here to help you document the development of new medical devices for FDA review and approval. We assist organizations through the development of industrial and medical products, including Class I, II, and III medical devices, laboratory instruments, and IVD systems. Contact us today to learn more about our services and our familiarity with design control processes.