Medical Packaging FDA Requirements

FDA regulations for medical packaging regulate the manufacturing process and ensure items remain safe and sterile.

When medication or medical devices are packaged, the integrity of their storage – whether it be pouches, trays, or blister packs – is incredibly important. The journey from packaging to shipping to storage and handling is a long one, and the contained device or medication needs to remain uncontaminated.

This is exactly why a wide range of medical packaging FDA regulations and requirements exist: to ensure that every medical manufacturing project is approached with the appropriate level of care, sterility, and traceability. FDA regulations dictate every part of the process, including:

• Design
• Manufacturing
• Packaging
• Labeling
• Storing
• Servicing

“Because the FDA has rigorous standards for the sterility of medical devices it approves, manufacturers must undergo thorough testing to demonstrate a package’s resistance to environmental factors that might threaten the sterility of its contents,” Jason Haider, founder and CEO of Xenco Medical, explains.

“This testing protects against factors such as the transport and aging of the packaging material itself, which could weaken over time and expose the contents to pathogens.”

“Packaging must undergo a spectrum of validating tests to demonstrate their ability to withstand environmental factors. These tests include bubble-emission and burst testing, among others.”

Updated FDA Requirements for Medical Device Packaging

As of January 31, 2024, the FDA issued the Quality Management System Regulation (QMSR) Final Rule, which amends the existing Quality System (QS) regulation by aligning more closely with ISO 13485:2016.

This move is designed to harmonize U.S. medical device regulations with international standards, streamlining compliance for global medical contract manufacturers.

While the rule doesn’t take effect until February 2, 2026, it reflects a growing emphasis on quality system alignment and risk management in medical packaging.

Medical Device Labeling Regulations

Even the labeling of medical devices is highly regulated, as outlined in several articles on the FDA’s official website. These medical packaging FDA requirements dictate that the following must be included on any label:

• A statement identifying the commodity that is packaged (tablets, sponges, medical implants, etc.)
• The name and place of business of the manufacturer, packer, and/or distributor
• The number of contents in terms of weight, measure, or numerical count

Additionally, all labeling must comply with Title 21 of the Code of Federal Regulations (CFR), particularly Part 801, which governs general medical device labeling requirements.

Janco’s Medical Device Packaging Process

Having spent over six decades serving the medical industry through a wide range of contract manufacturing projects, our team has a deep understanding of the comprehensive regulations and requirements in place, Janco employs a meticulous process to guarantee that our medical packaging projects are manufactured with strict adherence to the appropriate procedures.

Here’s what you need to know about our process:

• Our medical device and packaging inspection staff carry out diligent and comprehensive validation testing according to ASTM, ISO, or other custom industry standards, depending on your application.
• Any medical products manufactured at Janco offer complete traceability from individual product IDs, back to raw material lot numbers.
• Janco’s medical manufacturing division is certified to ISO 13485 and FDA registered.
• Our ISO 14644-1 Class 7 and Class 8 certified cleanrooms undergo ongoing monitoring and testing to ensure that they are operating within their required parameters.
• All of our medical packaging processes are regularly audited and verified through internal, independent, FDA, and customer assessments.

At Janco, we understand that the success of your medical packaging is determined by the efficiency and precision of its manufacturing. That’s why we’ve invested in the most innovative and effective technology to ensure that the packaging and products we create adhere strictly to FDA medical packaging requirements.

Want to learn more about our medical contract manufacturing capabilities?

Get in touch with our team to learn how we can add value to your next project!