Written by Dominique Engome Tchupo, Ph.D.
Senior Human Factors Researcher
Jumpseat Research
Introduction
Designing and developing a medical device involves a complex network of processes. A common thought throughout these processes is to get the medical device approved by the necessary regulatory authorities for deployment. However, what very few medical device makers consider (to their own peril) is that regulatory standards need to be present long before regulatory approval is sought as these could result in expensive and time-consuming changes.
The primary authority whose guidance one needs to follow depends on the region in which they aim to market their medical device. In the US, that is the FDA, specifically, the CRDH. However, the CRDH also adheres to guidance from other organizations of experts in the various intricacies of medical devices. While not all medical devices require FDA approval, it is still good practice to follow these additional standards to increase adoption rate, usage, safety, and enjoyment of your device.
Different Standard Organizations to Consider
The FDA has made available the Recognized Consensus Standards: Medical Devices database to provide guidance on which standards are accepted for the design and development of various medical devices.
Although there are many approved organizations and standards, the most referenced organizations are ISO, ANSI, IEC, and IEEE.
ISO – International Organization of Standardization
Figure 1: ISO Logo
This is a non-governmental organization made up of national standards bodies. It brings together experts in various fields to decide on the best way of doing things. It covers a broad range of fields, including climate change, healthcare, quality management, and artificial intelligence.
ANSI – American National Standards Institute
Figure 2: ANSI Logo
This is the US representative of the ISO and one of its founding members. While ISO develops standards that are internationally applicable, ANSI focuses on the US and adapts those ISO standards for US contexts.
IEC – International Electrotechnical Commission
Figure 3: IEC Logo
This is a global organization which provides guidance for quality electrical and electronic goods. Conformance to IEC standards is integral for the approval of medical devices with electrical or electronic components like various diagnostic machines, glucose monitors, and sensors.
IEEE – Institute of Electrical and Electronics Engineers
Figure 4: IEEE Logo
IEEE is an American professional organization of electrical and electronics engineers and other related professions. IEEE medical device standards primarily affect those devices that have a communication component.
Summary
It is important to note that compliance with ISO/ANSI or any other standards alone does not guarantee FDA approval, but it is good practice, nonetheless. It can also lend validity to your device to demonstrate that the standards have been met. Therefore, it is of paramount importance to work with a team familiar with these different guidance documents and the overall FDA process early on to help ensure high adoption rate, enjoyment, and regulatory clearance of your device when you take it to market.