Does FDA Require IEC 62304??

1. Does FDA Require IEC 62304?? Why this question arises? Medical device recalls, which are highly undesirable are not stopping are on rise. The devices which are coupled with software are amongst them and poses new challenges. Over a period with new development in IT, software use has become so much and inevitable, that one cannot say let us stop using them. The alternate way is to make it more controlled and regulated. Software use has become so much that in some medical device it is playing very important role which is so detrimental that it also needs to control so regulator has made that software itself as medical device, so it automatically get governed by all applicable regulations. IEC 62304 standard came into existence due to above facts only. The standard is designed to provide lifecycle approach to govern software. Life cycle approach with activities and tasks to govern safe software design and maintenance of the same. Each life cycle process is further divided into many sets of activities and each activity is further divided into set of tasks. Since it is maintained under quality management system as being part of medical device it is automatically also governed with Risk management requirement as per ISO14971. Any additional risk management requirement, if necessary, can also be governed by standard risk management approach. This approach will identify any hazard which may be possible due to software and can avert the hazard. This standard essentially deals with software development process and software maintenance process. Standard describes various steps of software deign steps like, Software development planning, Software requirement, architect design and many more finally the software release. This involves risk management also. After release comes the configuration management and problem resolution. This follows system maintenance management and risk management. Thus, complying to IEC 62304 enhances the reliability of software which is exactly FDA is looking for. FDA also believes that product testing alone is not enough to believe that software is safe for patient using that medical device. We all know that it is common practice to switch off and on again or delete and re-install are common practice to a trouble shoot where software errs or does not work.

2. Can you do this for medical device software where it’s use is very much linked to performance command. This standard is recognised in most countries, and many follow them. Even IEC standard for 60601-1 for electrical safety in medical devices also has incorporated in clause14 compliance to IEC 62304 where needed. (Where software has essential performance role, where PESS-Programmable electronic safety system poses unacceptable risk) Many software manufacturers makes that they do not determine clearly which element of risk their software mitigates. IEC 62304 wants that element must be addressed. It is now very clear that software engineer is usually not a medical personal and he designs and develops software based on user’s need, usually manufacturer or medical device user doctor. Compliance to standard regulating such aspects as mentioned above are not their expertise. It is therefor advisable to seek a support from expert consultant like IZiel so that all compliance need for IEC 62304 is met and FDA approval also becomes easier.