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Preamble to quality system regulation serves as valuable compliance tool.

When is a preamble to a federal regulation worth reading? When it provides understandable guidance and practical advice on how to adhere to the regulation itself. That’s the case with the preamble to Title 21 Part 820 of the Code of Federal Regulations. Commonly called 21 CFR Part 820 or the QS (quality system) regulation in our industry, this regulation covers, among other thing, quality management and organization, medical device design, buildings, equipment, purchase and handling of components, production and process controls, packaging and labeling control, device evaluation, distribution, installation, complaint handling, servicing, and records. The preamble to that regulation—running some 43 pages in the Federal Register—is invaluable, both as a teaching tool and a roadmap of sorts for how to handle U.S. Food and Drug Administration (FDA) inspections, and third-party audits of contract and medical device manufacturers. Before I teach, conduct an audit, or embark on another FDA inspection, I pull out my dog-eared copy of this document and refresh my knowledge with this valuable insight into the meaning and intent of the QS regulation. The preamble is the mainstay in my permanent traveling files—on my “must-read” list at thirty-five thousand feet. Preambles are the notes that FDA publishes when it announces a proposed or final rule. They include comments submitted by industry and the public and the FDA response. As such, preambles often reveal the intent and FDA’s interpretation of a regulation. With the preamble to the QS regulation, these comments from the FDA have, over the years, become informal policy and are commonly referred to when, for example, establishing a regulatory position, defending an FDA inspection point, or training medical device professionals to the nuances of the regulation. Basically, the comments have been timeless. This is the “in-between-the-lines” information that supports and, in many cases, drives the regulatory verbiage. (Occasionally, FDA’s thinking has evolved. An example is comment #85 on page 52621 which states, Preamble to Quality System Regulation Serves as Valuable Compliance Tool