Jun 03, 2021 Kelly Stanton

3 Important FDA Medical Device Guidance Documents to Bookmark

Are you struggling with medical device regulatory compliance?

If so, you’re not alone. It’s an issue that thousands of growing medical device startups and scale-ups face during early growth. Unfortunately, when left unchecked, non-compliant manufacturing and quality management processes can result in serious fines or penalties.

If your company is vulnerable to regulatory compliance issues, establishing key corrective and preventative actions (CAPAs) is paramount to the long-term success of your growing medical device organization. 

To steer your efforts in the right direction, you’ll want to utilize FDA medical device guidance documents. The FDA routinely issues guiding documentation designed to help medical device manufacturing organizations navigate the complex regulatory landscape, activate compliance best practices, and avoid major regulatory pitfalls. 

To make things easier on your end, we’ve compiled a list of the top three FDA medical device guidance documents that you need to bookmark to achieve rapid and sustained regulatory compliance. 

3 FDA Medical Device Guidance Documents to Bookmark

COVID-19 has placed major emphasis on effective medical device manufacturing and quality management. Many medical device organizations have adopted a remote-first approach to work. Additionally, auditors have been forced to limit on-site inspections.

To streamline manufacturing, quality assurance, and compliance, many growing medical device organizations have invested in quality management system (QMS) solutions. From document management to design control, an effective QMS gives startups and scale-ups the information needed to ensure compliance success. And when you pair your QMS with the FDA guidance documents below, compliance is almost guaranteed. 

1. COVID-19 Related Documents

Many growing medical device organizations were blindsided by the COVID-19 pandemic, which begs the question: How would you rate your company’s emergency preparedness and response plan?

Fortunately, the FDA has issued COVID-19 related guidance documentation that outlines various practices and procedures related to disaster recovery, emergency response, and emergency use authorization (EUA). 

The FDA has even developed a new Medical Countermeasures Initiative (MCMi) to help medical device manufacturers develop products to safeguard the public from global threats such as COVID-19.

In recent months, the FDA has issued strict guidance on the development and distribution of COVID-19 vaccines. In the event that your medical device startup is developing a product for emergency use, we recommend consulting pre-authorization guidance documentation. This documentation outlines the exact steps that your startup must follow to achieve authorization prior to an emergency declaration.

RELATED READING: How to Build an FDA Audit Strategy During the COVID-19 Pandemic

2. Product-Specific Guidances for Generic Drug Development 

According to FDA product-specific guidance for generic drug development, manufacturers must demonstrate bioequivalence to a reference listed drug (RLD). The generic drug must contain all of the same active ingredients as the RLD. Generic drug manufacturers must also follow the same dosage amounts and administration methods (e.g., intravenous, oral, and intramuscular)

The FDA issues in-depth guidance related to generic drug development, as well as the processes and tests manufacturers must follow to ensure bioequivalence. It’s important to reference this guiding documentation during early-stage development. 

We also recommend investing in a QMS purpose-built for the medical device and biopharmaceutical organizations. By doing so, your pharmaceutical organization can easily develop products in accordance with major FDA quality requirements.

RELATED READING: The 5 Noticeable Benefits of Implementing a Quality Management System in 2021

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3. Clinical Trials Guidance Documents

When building a product for clinical trial, the FDA offers clinical trial guidance documents designed to aid in the manufacturing, development, and distribution of the product. The FDA typically places an increased focus and emphasis on Current Good Manufacturing Practice (GMP) requirements for products set for clinical trial. 

When you consider the benefits of an effective clinical trial (e.g., testing new products/drugs and developing potentially life-saving treatments for new diseases), it makes sense that the FDA subjects manufacturers to strict governance requirements.

In addition to the FDA’s guiding documentation, you’d also be wise to consult 21 CFR Part 314. This subsection outlines the standard processes and procedures new medical device manufacturers and biopharmaceutical organizations must follow to achieve FDA approval to manufacture, market, and distribute a new product or drug.

RELATED READING: The 4 Phases of Clinical Trials (And How to Guarantee Quality Assurance During Every Step)

Access Free Life Sciences Quality Management Guidance

The documentation outlined above will give your growing medical device or biopharmaceutical organization the leverage it needs to achieve and maintain FDA compliance. 

But how will your organization utilize this documentation?

To figure that out, we invite you to download our free resource: 7 Ways to Improve Medical Device Quality

In it, you’ll see that effective medical device manufacturers follow a step-by-step process to ensure that products are being developed in accordance with new and evolving quality requirements. 

Good news: An advanced QMS allows quality professionals to manage every aspect of the product lifecycle, including the review process, training management, document control, reporting, and more. 

Check out the guide to learn about all the procedures that your organization must follow to use quality as a means to outpace your competitors and create products that meet (or exceed) quality standards and practices. 

Here’s to bringing quality medical devices to market — on your timeline, not the regulator’s.

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Published by Kelly Stanton June 3, 2021