What is the FDA 21 CFR? Requirements Overview

What is the best way to ensure that your medical device complies with all applicable laws and regulations? 

Title 21 of the Code of Federal Regulations (CFR) sets the standard as the foremost regulatory authority for medical devices.

Take a look, and you’ll see that it covers everything from opthalmic preparations to public hearings. 

Of course, it can be easy to get overwhelmed when looking for critical information relevant to your unique use case or application. However, identifying the portions of FDA 21 CFR that do apply is critically important to the ongoing success of your life sciences venture.

To strengthen the regulatory effectiveness of your growing startup or scale-up, we’ve summarized the critical highlights of FDA 21 CFR. 

Use this guiding resource to gain a quick understanding of your product’s specific regulatory requirements and streamline your path toward rapid FDA approval.

FDA 21 CFR: Requirements Overview

FDA 21 CFR is a codified rulebook designed to protect consumers’ health through the development of safe and effective products. 

From design and clinical evaluation to manufacturing and post-market surveillance, FDA 21 CFR covers a wide range of topics related to human and veterinary products, biological products, and medical devices.

There are five regulatory bodies that contribute to a yearly revision of all nine volumes across the following three chapters. Each year, revised volumes of FDA 21 CFR are published by the Office of the Federal Register (OFR). To access the most current version of FDA 21 CFR, visit the Electronic Code of Federal Regulations.

This overview will cover the requirements in Chapter 1 of FDA 21 CFR as they apply to manufacturers of medical devices, drugs, and other biopharmaceutical products.

200 Series: General Drug Requirements

Subchapter C “Drugs: General" governs the standards for Current Good Manufacturing Practices (cGMP), including “requirements for personnel, buildings and facilities, equipment, product containers, packaging, laboratory controls, records, reporting, quality control unit, and routine pharmaceutical quality training.”

FDA CFR 200 Series requires that all medical device labels clearly and consistently include information related to pricing, as well as associated fees, including handling and mailing. 

This regulation also includes prescription drug labeling, marketing, and advertising, and mailing of pharmaceutical information to physicians.

300 Series: Human Drugs Requirements

Subchapter D “Drugs for Human Use” outlines all pertinent regulatory requirements for new drugs, including over-the-counter medications. 

Additionally, this subchapter sets forth the manufacturing principles surrounding controlled drugs and substances. Inside, you’ll find an updated record of all official and established drugs approved by the FDA.

What’s more, this portion of FDA 21 CFR details the submission process for new product applications and explains, in detail, all pre-submission requirements. 

The purpose of these guidelines is to ensure that all new products are safe and effective for use. In this chapter, medicinal drug manufacturers have access to all the required documentation needed to streamline the pre-approval process and avoid regulatory audit.

600 Series: Biological Products 

Subchapter F “Biologics” governs all biological products, including the licensing, production standards, and general usage. 

This mandate extends to all biological products — including vaccines, therapeutic serums, and antitoxins used to cure or prevent an ailment, condition, or disease.

When you consider the high-risk nature of these products, maintaining cGMP is critical. In most cases, an investment in an electronic quality management system (eQMS) will lay the foundation for effective document management, quality assurance, quality control, and as a result, manufacturing processes, including quality standards, methods for measuring success, and preventative and corrective action (CAPA).

800 Series: Medical Devices 

Subchapter H “Medical Devices” outlines labeling, production, reporting, and registration of all medical devices. It also details the premarket approval process and associated classifications of all medical devices based on type and use.

Device requirements are broken down into categories based on product type — including immunological, microbiological, cardiovascular, and neurological products. 

For a complete list of medical device manufacturing and classification procedures relative to your unique use case, review Part 860 “Medical Device Classification Procedures.”

1000 Series: Radiological Devices 

Subchapter J “Radiological Devices" spells out all regulatory requirements for radiation-emitting devices, including radiological devices used in medical imaging and surgery settings — and also those used in security systems, laser light shows, and even tanning salons. It is the responsibility of all radiological device manufacturers to create and distribute products that are safe and effective for use.

Performance standards are outlined in Sections 1110-1050 of FDA 21 CFR. Additionally, the Center for Devices and Radiological Health (CFRH) mandates that all device defects, including deviations in performance standards, be communicated clearly and efficiently.

Understanding FDA 21 CFR 

To achieve rapid FDA approval, your organization must develop an understanding of the FDA 21 CFR requirements that apply to your unique situation. 

The good news is that you don’t need to navigate this complex process alone.

Qualio’s industry-leading eQMS comes with all the features and benefits that you would expect from a modern solutions provider. 

On top of that, our advanced technology can help your organization to establish clear audit trails as well as good manufacturing practices related to document management, quality assurance, and training. 

Simply put, our eQMS gives you all the quality tools you need to successfully grow your life sciences startup or scale-up. 

Which begs the question: Are you ready to improve the quality of your product?

If you’re unsure where to start, check out our free guide: 12 Questions to Ask Before You Buy an eQMS. 

Read it to learn more about the most important questions you’ll need to ask eQMS vendors as you figure out which solution to invest in. After reading, you’ll have all the information needed to find an eQMS tailored for your unique use case.