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FDA Design Controls Explained

Developing new medical devices allows companies in the healthcare industry to grow their businesses, improve health outcomes for patients, and drive innovation. To make sure these devices comply with the proper standards, manufacturers need to follow design controls outlined by the Food and Drug Administration (FDA).

Design Control for Medical Devices: Purpose

The design control system details the design process for medical devices to make sure these products meet intended uses, user requirements, and other specifications. The following stages outline the design control process for developing FDA-compliant medical devices:

  • Design and development planning
  • Identifying design inputs
  • Developing design outputs
  • Verifying that design inputs match design outputs
  • Validating the design
  • Checking design changes
  • Reviewing design results
  • Transferring designs to production
  • Creating a design history file

Design Control for Medical Devices: Design & Development

At Omnica, the vast majority of our clients—from small startups to established Fortune 500 companies—partner with us to help them develop high-quality medical devices and instruments of all kinds.

Regardless of the size of their business or the product they want to make, our clients share two main goals: to fully realize their ideas and to overcome the regulatory challenges pertaining to the design and development process of their company’s quality system. Specifically, they want to ensure compliance with the FDA’s Code of Federal Regulations Title 21 Part 820 Quality System Regulation (21 CFR 820 QSR), which is mandatory for all medical device manufacturers.

Most medical device manufacturers must also obtain ISO 13485 certification, which is an international regulation for the quality management systems of medical device makers. 

Design Control for Medical Devices: Classes

Most medical device recalls occur because of design issues. This is why, in 1996, the FDA revised the Current Good Manufacturing Practice (CGMP) to include a section on design controls, which became known as Title 21 CFR Part 820:30. 

According to this revision, manufacturers of any medical devices in class II, class III, and paragraph (a)(2) of class I must establish and adhere to procedures that control the devices’ designs, ensuring that they meet all industry requirements.

Examples of medical devices that fall under these three classes include:

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Design Control for Medical Devices

Class I Devices

  • Bedpans
  • Wellness apps
  • Elastic bandages

Class II Devices

  • Pregnancy testing kits
  • Surgical needles
  • X-ray machines
  • Apple Watch

Class III Devices

  • Pacemakers
  • Breast implants
  • Knee implants

Design Control eBook 

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In this eBook, you’ll find an introduction to the design controls section of regulation 21 CFR 820.30. This information provides guidance for medical device manufacturers regarding regulatory strategies for designing and developing new medical products. At the end of the eBook, you’ll find a list of references directing you to additional information about the development of medical devices, FDA design controls, other quality system regulations, and interfaces that manufacturers need to manage. 


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Work with Omnica for Design Control for Your Medical Devices

At Omnica, we have expertise in design engineering and R&D, particularly in the life sciences industry. Additional areas of expertise include electronics engineering, software engineering, mechanical engineering, and prototype development. Depending on each product’s design input requirements, we provide design output and transfer the subsequent results to the client, who can then incorporate the results into their quality systems for design controls. This allows them to compile their design history file.

For more than 36 years, Omnica has continued to refine engineering and business practices for all programs to ensure consistent top-quality output. We connect our design team with our client’s project manager to maintain open and clear communication on every project. This connection is mutually beneficial in helping the client maintain FDA design control compliance and promoting creative product design. 

If you have any questions or would like to start working together on your next design project, contact us today.