The Food and Drug Administration (FDA) utilizes regulatory standards developed by non-governmental organizations as regulatory criteria for medical devices, these are referred to as recognized consensus standards [1]. Examples of some of the organizations that develop these standards are: International Organization for Standardization (ISO) standards, American Society for Testing and Materials (ASTM) standards, American National Standards Institute (ANSI) standards, International Electrotechnical Commission (IEC) standards, etc. The IEC is an organization that develops standards to standardize the electrical and electronic fields [2].
IEC 62304 is a standard procedure for the lifecycle processes of software that is integrated into medical devices. This specific standard is an FDA recognized consensus standard [1] that establishes the safety and effectiveness of a medical device that contains software [2]. This standard lasts the whole lifecycle of the software development and implementation into the medical device, including the planning stages, development stages, and post market surveillance.
Compliance to the IEC 62304 standard applies to the development and maintenance of medical device software and is determined by inspection of all documentation required by the standard as well as risk management (ISO 14971 compliant) [2]. Medical device manufacturers assign a software safety class (A, B, or C) to each software system being implemented into the medical device. Severity of these classes are as follows: Class A – no injury or damage to health is possible; Class B – Non-serious injury is possible; Class C – Death or serious injury is possible [2]. Utilization of risk control measures is crucial to mitigate software-caused injuries and to reduce the safety classifications from C -> B and/or B -> A [2]. Implementation of IEC 62304 and its compliance is crucial to the wellbeing of users of the medical devices that contain software.
If you need help understanding the regulatory standards to properly classify and maintain your medical device for FDA compliance, the team of experts at EMMA International can help! Contact us today at info@emmainternational.com or by calling 248-987-4497.
[1] FDA. (2019, January 14). Recognized Consensus Standards. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=38829 [2] IEC. (2006, May). IEC 62304:2006 – Medical device software – Software life cycle processes. International Electrotechnical Commission. https://www.iso.org/standard/38421.html
