The Best 21 CFR 7 Checklist for Medical Device Startups

If you had to issue a product recall tomorrow, would you be ready?

According to the U.S. Food and Drug Administration (FDA), a recall removes and corrects products that violate major consumer protection laws and regulations. 

Unfortunately, improper manufacturing techniques and nonconformance issues routinely result in product recalls. It’s a problem that thousands of early growth startups and scale-ups face each year.

Fortunately, 21 CFR 7 outlines the unique policies, procedures, and responsibilities of medical device organizations undergoing a product recall. 

However, it can be difficult to know which steps your organization must follow to ensure and deliver a seamless and compliant product recall. Without an intimate understanding of 21 CFR requirements, the process can be a bit slow and arduous.

21 CFR 7: How to Prepare for a Product Recall

Avoiding product recalls altogether requires a strong quality management process. The most common quality management processes include nonconformance identification, corrective and preventative actions, supplier management, and more.

In most cases, investing in a quality management system (QMS) is the single greatest thing that you can do to streamline quality management and effectiveness. When unforeseen product recalls occur, a QMS gives you a bird’s-eye view on mission-critical data and documentation. It’s this kind of insider intelligence that will strengthen your medical device organization’s product recall response. 

Beyond investing in a QMS, here are a few other ways your organization can prepare for a product recall and comply with major 21 CFR 7 requirements.

1. Identify Product Recall Severity

The total depth of the product recall depends on the degree of hazard to the consumer and the extent of distribution. Your recall strategy should specify the distribution chains (e.g., consumer level, retail level, or wholesale level) most affected by the recall.

Typically, the product manufacturer is responsible for activating effectiveness checks to verify that the right people have been notified about the recall. Additionally, it is the manufacturer’s responsibility to ensure that corrective/preventative actions take place. 

In short, it’s essential that your plan includes the processes and procedures for notifying the right people at each level of the distribution and supply chain.

RELATED READING: 5 of the Best Options for Nonconformance Management Software

2. Issue a Public Warning

The purpose of the public warning is to notify the public that the product being recalled presents serious or adverse health hazards. In coordination with the product manufacturer, the FDA will usually be the one to issue these kinds of warnings.

Be sure to have the following information prepared prior to the FDA’s public warning:

• Product recall classification
• Associated health hazards
• Number of products being recalled
• Product lot numbers or other product identification numbers
• Instructions on how to contact the manufacturers
• Instructions on how to return affected products to the manufacturer

3. Conduct Effectiveness Checks

The purpose of the effectiveness checks is to verify that the right people and organizations at the specified recall depth have received notification about the product recall and have taken the appropriate action. 

These organizations, also referred to as “consignees,” may be contacted through personal visits, telephone calls, letters, or a combination of these methods.

For more information related to consignee communication, we recommend consulting Product Recalls, Including Removals and Corrections. 

RELATED READING: 5 FDA Audit Preparation Tips for Life Science Startups

Proactive 21 CFR 7 Planning With a Quality Management System

Avoiding a product recall should be your organization’s top priority. 

The best way to stay prepared and mitigate the risk and severity of a product recall includes the investment in a modern QMS. The compliance safeguards and integrated quality processes ensure that you have all the data, documentation, and information needed in a product recall.

The significance of moving from a paper-based system to a digital system cannot be understated. To get started, we recommend downloading our free guide: How to Migrate from a Paper-Based System to QMS Software.

Read the guide to learn about what you can do to plan for a smooth and seamless system migration. 

Remember, Qualio’s onboarding and customer success teams are here to ensure you have the tools and resources you need to maximize system adoption and usage. By investing in Qualio, you get the peace of mind that comes with knowing you’re never on your own.