Title: History of Quality Regulations
Course: PW-Course-Import-Test > Section: Module 1: Introduction to Medical Device Quality Systems

Module 1

This section of the course will provide some basic history as to why quality regulations exist and how the United States (e.g. FDA) settled on the final written language (Final rule) of these regulations. We will then explore each section of the medical device regulation (21 CFR 820/QSR).

Read

Read Milestones in Food and Drug Law History, which provides a detailed history of the evolution, components, and influences of the Quality System Regulation.

The United States has a demonstrated track record of progressive innovation and economic growth. During periods of high growth/high innovation, potential impact to the population of the United States may lead to a national conversation about the need for industry regulation.

Why was there a need to regulate Food and Drug manufacturing?

The Pure Food and Drug Act was originally composed in 1906. Watch History of the FDA, a short video of the history and evolution of 21 CFR 820.

Watch

History of the FDA

What were some of the early influences that led to the development of the regulations?

In the early1900’s (and probably much sooner than that) several significant events occurred that, in turn, stimulated the debate for the need to establish regulations.

Read

Read about how the Pure Food and Drug Act came into existence.

Who do the regulations protect?

Read

Read the Federal Food, Drug, and Cosmetic Act. It provides additional history to learn why consumer protection oversight by the FDA is required.

Read the Federal Food, Drug, and Cosmetic Act (FD&C Act) page on the FDA Website. Because the Code of Regulations is very broad and comprehensive, specific industry segments have been defined so that regulations could be developed around specific categories. This webpage provides a navigation menu on the left side of the page that can take you to these specific categories.

Watch

FDA: A History - Pre 1906Watch another history of the FDA discussing how the original motivation driving the development of the regulations was to protect the health and safety of American consumers.

How was it possible to develop a broad, comprehensive set of regulations that the Medical Device Industry would accept?

After providing an “open comment”period to receive feedback from industry, the FDA arrived at the final language in the QSR.

Read

Read the rationale for the “final rule” in the Preamble where comments that are related to specific sections of the regulation can provide additional clarification as to the intent of the regulation.

Why is the Preamble important?

21 CFR 820 (Quality System Regulation - QSR) defines requirements that are intentionally broadly scoped. The written content of the QSR has been described by Industry as “a mile wide and an inch deep.” One of the reasons for this is to allow flexibility while also establishing the requirement to establish controls.

The Preamble provides context and clarification regarding the intent of the Regulations.

Why is important to have individuals on staff that understand the regulations?

Medical Device manufacturers (that meet specific criteria) are required to establish a Quality System to comply with the Act. Knowledgeable people are required to make this happen. Although reading the regulation and preamble is not the most exciting educational activity, students that hope to seek employment in the Medical Device industry will benefit from the additional credibility that they will be able to establish during the interview stages when they have some background knowledge to express. This is a wise time investment for the medical device job seeker.

Reinforce your knowledge of the regulations.

Read

Now that you know the history of the development of the regulation, it is time to read it. Reading it will help you understand the depth and width of the regulation that was created to define how the medical device industry shall comply.

Read 21 CFR 820 Quality System Regulation

Watch

As you are reading through 21 CFR 820, watch this narrated presentation Introduction to Quality Systems Overview. It will walk through the various sections of CFR 820 and give examples of quality systems that meet the requirements.

In addition to this presentation, YouTube has many free videos like the following that provide a general overview of the QSR:

GMP for Medical Devices Overview ( FDA 21 CFR 820 ) (Links to an external site.)

Subsequent modules will highlight and provide a deeper dive into the specific subparts of the regulation.