Emphasizing design controls can assure good design and engineering practices that yield high-quality solutions. This is critical when considering U.S. Food and Drug Administration (FDA) validation and design compliance. To accomplish this, first know what key elements should be incorporated in design controls before implementing formalized plans for creation.

Establishing sound design controls can prevent FDA inspection observations and Form 483s – which can be very costly and even derail product launches. Form 483s and FDA warning letters are similar and inform all affected parties regarding issues that require corrective action. Form 483s, also called Inspectional Observations, convey conditions or practices that indicate a potential violation of FDA requirements. The warning letter is typically an escalation from insufficient follow-up.

Maintaining compliance

Approximately 90% of 2018 FDA 483s cite Quality System Regulation issues (21 CFR 820), which are very concerning. The chart on page 31 shows 14% are design control issues (CFR 820.30) as well as corrective and preventive actions (CAPA). The consequences are significant to affected companies.

Medical device manufacturers hope to avoid being listed on the FDA website, as this kind of visibility can be detrimental to future sales and profitability. Patients and physicians may lose confidence in the device, and medical device makers are at risk from competitors exploiting the information. Lastly, management and other resources can be pulled from priorities to address these issues, which can disrupt business operations.

A solid design controls foundation simplifies FDA compliance, allowing companies to pass audits without findings.

Design controls

Design and development planning is the first element in the design control process. The plan includes activities, dates, and responsible people and is documented and updated as it evolves. Next comes design input from users, patients, and physicians, along with other stakeholders. The design process results in design output – documentation describing the product.

Design reviews take place throughout design development to check the design results and identify issues. Verification ensures that the designs completely and unambiguously match the design input. During verification, personnel should be able to answer questions such as:

• Do we have all needed documentation?

• Who has approved it and when?

• What’s missing?

Design transfer

is the process of providing manufacturing with the design output they need, including bills of materials (BOMs), drawings, and assembly instructions. Design transfer is not frequently cited in 483s, yet companies frequently have issues during transfer because they send information manually from engineering to operations, increasing the risk of delays and errors.

The validation stage tests to make sure the manufactured product meets the users’ needs. All tests and results must be documented. FDA officials most commonly reference validation issues in design controls 483s.


Design changes are the second-most cited issue under design controls. After releasing the first revision, updating enterprise resource planning (ERP) and other downstream systems can be tricky. Many aspects of the design may have changed, making it essential to understand what has been added or removed. It’s also important to ensure supporting documents have been updated. Change processes can have many variables, making documenting and following those processes more difficult.

The design history file (DHF) becomes the compilation of a company’s product design documentation and its evolution. This is an administration-heavy element that can be cumbersome. Traditional, document-centric quality management system (QMS) solutions can simplify some of these processes. However, a product-centric QMS leverages a single system to manage the foundational product record in context with related quality processes. This connected product record includes a relational BOM, approved manufacturers list (AML), and engineering change orders (ECOs). Managing the quality processes in the same system creates better visibility of issues and faster resolution with connected quality records such as complaints and CAPAs that can drive ECOs to correct any design issues.

Ultimately, having a product-centric QMS helps companies with the design transfer and design change processes as well as the FDA required file management. This also allows medical device companies to establish solid design controls to avoid FDA warnings that can result in lost revenue, patient health issues, or, in some cases, death.

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