Resources & Articles

Medical Packaging FDA Requirements

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

Operating in the field of medical packaging requires strict adherence to a set of unique industry standards. Several important steps have to be taken to authenticate the integrity of materials, sealing, and even how packaging will age over time.

So, what do you need to know about FDA requirements and regulations?

The good news is, we can take care of all of it for you, from design to labeling, but it’s still important to understand why these regulations exist and how seriously we take them.

FDA Regulations for Medical Packaging

When medication (such as tablets) or medical devices are packaged, the integrity of their storage – whether it be pouches, trays, or blister packs – is of the utmost importance. The journey from packaging to shipping to storage and handling is a long one, and the contained device or medication needs to remain untampered with.

This is exactly why a wide range of medical packaging regulations exist, to ensure that every project is approached with the appropriate level of care and sterilization. Regulations dictate parameters for every part of the process, including:

“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.”

Medical Device Labeling Regulations

Even the labeling of medical devices is highly regulated, as outlined through several articles on the FDA’s official website. The 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.

Janco’s Medical Packaging Process

Understanding the comprehensive regulations and requirements in place, Janco employs a meticulous process to guarantee that your medical packaging projects are manufactured with strict adherence to the appropriate procedures. (See our certifications here.)

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 ID, 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 assure 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 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 guidelines.

Need an expert team to carry out a custom medical packaging project?

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