Understanding FDA’s Interpretation of Medical Device Design Control

Understanding the FDA’s thinking and working with the agency is the best way to accelerate compliance. Two important areas in which FDA commonly finds noncompliance issues are in design control and document management. However, some of the shortest descriptions in CFR 21 Part 820 Quality System regulation are found in Sec. 820.30 and Sec. 820.40, on those topics (the sections total about a page of written language on design and document controls). Regardless of their length, however, these two sections can be the most complex aspects of medical device controls when a company is actually trying to complying with the regulation. Companies are at risk of a stop shipment of product or something worse if FDA finds a flaw in the design and document controls. Compliance failure is not an option when the goal is to provide an uninterrupted flow of product to the market place and ensure a steady stream of revenue for a successful business plan.

FDA does provide a bit more background to help new medical device companies with these two key elements (see Medical Device Quality Systems Manual, A Small Entity Compliance Guide). However, even those few pages of guidance (covered in Section 9: Document and Change Control) fall short of the detail needed to understand the impact to a company’s quality system. The good news is that there are some great tools that can help mitigate these complexities and streamline controls. The bad news is that it still takes a very strong detailed and sustained effort to ensure these complex controls are in place for continued success and compliance with regulation.

With a variety of suppliers come a variety of processes, procedures, and controls that are developed specific to a business and to the devices being produced. It is important to understand how FDA tries to normalize a specific business to the regulation when auditing that business for design control compliance. Understanding the agency’s view will help make for smoother comparisons and analogies for suppliers, as well as a much cleaner and successful audit of a company’s design processes.

A simplistic model can be derived from the 820.30 regulation that FDA may use to ensure design coverage and compliance of a device design and manufacture to the regulation. The design and development model can be graphically depicted and loosely linked to the regulation, as pictured above.

Diagraming out the design flow illustrates a more detailed picture of the delivery flow, validation, and verification of a product against its intended use model. It is specifically important to FDA that each and every stage of the process is well reviewed and documented.

Again like the FDA regulation on design controls, this is a very short summary of complex processes, document definitions, controls, management, and approvals, for which there have been volumes of books written. The objective should be to have a very good understanding of how FDA or another regulatory entity views the device controls such that a business can demonstrate how its particular controls map into the regulatory model. A logical analogy of a business’ design and development model should be able to map to the regulatory normalized base line models. In doing so, the model results in smoother audits with a higher degree of success and hopefully (something the regulatory folks don’t really care about but as a business we all do) a decrease in expense and time in managing the audit process.

Understanding FDA is key element to a more streamlined and smoother compliance with regulation. It is important to keep in mind not just the business drivers but also FDA’s view of design controls. Understanding this perspective, along with paying close attention to developing a product development process and product life cycle model, will pay huge dividends toward maintaining compliance, avoiding FDA action on a company, and minimizing interruption of the overall business plan.

This blog was adapted from a longer white paper, which explains how to maximize the use of enterprise level business tools that accelerate process, streamline audits, and accelerate FDA compliance. Get the full detailed White Paper here

Dennis Payton is executive director of product marketing with Expandable Software Inc. He has 23 years of engineering, product management and executive management experience. He holds a BS in electrical engineering from California Polytechnic State Univeristy, San Louis Obispo, and post studies at Stanford University, University of California, Santa Cruz, and UC Berkley Haas School of Business.