Understanding FDA Standards for Medical Device Carrying Cases and Garments


At Fieldtex Products, we specialize in manufacturing high-quality carrying cases and medical garments designed specifically for portable medical equipment. Our commitment to quality and regulatory requirements is especially important to us. What is the FDA looking for in a sewing factory and what is the significance of ISO standards in our manufacturing processes?

Clarification on FDA Certification

First, it is important to understand that the U.S. Food and Drug Administration (FDA) does not certify clothing or medical garment manufacturers. The FDA primarily covers and regulates the safety of food, dietary supplements, medications, vaccines, biopharmaceuticals, blood transfusions, radiation-emitting devices, and veterinary products. Medical garments and other forms of clothing, including those for medical use, fall outside the FDA’s regulatory scope in most cases because they are not considered true medical devices.

At Fieldtex, we are committed to maintaining the highest standards of quality and safety in our manufacturing processes, though the FDA does not certify factories like ours. It is important to find a manufacturing partner that understands where the medical device line lays, we want our customers to be fully informed about this distinction and to trust in our dedication to meeting the regulatory guidelines on either side of the medical device distinction.

Importance of ISO Certifications

More commonly we see ISO certifications play a crucial role in the global market for medical devices. These certifications demonstrate that a product meets international standards for quality, risk management, and safety. For medical device developers and manufacturers, ISO certifications have historically functioned as a trust signal for a factory’s ability to produce high quality and strong internal controls.

The process we went through in achieving ISO 9001:2015 certification required time, effort, and investment, but the benefits are substantial for our customers. Along the way to getting certified we upgraded and changed many processes in our training and quality check processes. Which has led to cutting down on turnover and, more importantly, dropped our end-of-line repair work to less than one percent in the last year.

Detailed Look at ISO 10993: Biocompatibility

One of the key ISO standards relevant to wearable medical garments is ISO 10993, which focuses on the biocompatibility of medical devices. This standard is essential because medical wearables unavoidably come into contact with patient’s skin. Testing for biocompatibility helps protect patients and healthcare workers from potential biological risks. While we unfortunately do not provide this type of testing, we work with our customers through the prototyping and testing process.

ISO 10993 provides a comprehensive framework for testing the biocompatibility of medical devices. The specific tests required depend on several factors, including the type of device, its material, intended use, and the nature and duration of contact with the patient. ISO 10993 Commonly requires tests including hemocompatibility, sensitization, and cytotoxicity. The latest revision also requires a Biological Risk Assessment, a critical yet complex step in ensuring device safety.

Our Compliance and Expertise

At Fieldtex Products, we pride ourselves on our track record of working closely with medical device developers. We offer lot traceability and adherence to ISO standards in our manufacturing processes, ensuring that our products meet the highest levels of quality and safety.

Our expertise in producing custom medical garments and carrying cases means that we have experience in the unique needs of the medical device industry. We are committed to delivering products that not only meet but exceed regulatory requirements.

Navigating ISO Standards

In addition to ISO 10993, several other ISO standards are commonly applied in the medical device industry:

  • ISO 14971: Focuses on risk management for medical devices.
  • ISO 62304: Pertains to the software life cycle processes for medical device software.
  • ISO 13485: Relates to quality management systems for medical devices.

Understanding and meeting these standards can be challenging. For companies navigating these requirements, consulting with experts can be invaluable. If you have questions, Fieldtex Products is always ready to provide answers and guidance to ensure compliance.