Considering the slew of regulations that exist for medical devices today –to the extent that this is among the areas of the highest regulation from the FDA –it is rather ironical that the US Congress had not empowered the FDA to regulate medical devices till as recently as mid-1976. This is when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA). This was about seven decades since the FDA was first formulated in its earliest avatar.
The reason for which medical device software started getting regulated during this time is that it was in the mid-1970’s that computer software started to grow and evolve into a field of its own. Being in a state of infancy for most of that decade; it was only towards the end of the next decade that software began to get used in medical devices, albeit in a manner that appears rather crude by today’s standards. Because of this, the FDA did not have the need to create a software regulatory policy.
Separate regulations based on the nature of devices and software
Since then, however, software has made giant strides in its uses in medical devices. The growth has been so fast and wide-ranging that today, there are regulations for:
o Software that can be a device by itself (i.e., stand-alone, or what the FDA calls Software as a Medical Device or SaMD)
o Software that is incorporated into another device as a component, part or accessory.
Other factors to be taken into consideration
So, the FDA’s regulations on medical device software are based on its thinking that there is a distinction between stand-alone software and software that is a component, part or accessory to a device. Also, software validation is a major theme for most manufacturers of medical devices. Software validation of medical devices has to be not just satisfied; it has to be evidenced from a number of stringent perspectives. There is a clear distinction between medical device software and medical device hardware. Additionally, there are design user requirements to be met, and off-the-shelf software and automated equipment have to be validated.
In the realm of clinical valuation of an SaMD; the FDA requires medical device manufacturers to meet and demonstrate reasonable assurance of safety, performance and effectiveness since these devices have a very major impact on the health and safety of its users. This clinical evaluation has to thus be thorough and systematic, and should be well planned. The FDA’s clinical valuation of an SaMD should meet the following:
o Clinical validity
o Scientific validity
o Clinical performance
o Analytical validity
Deep and clear understanding
Professionals who work in the field of medical devices and whose work is related in some or another way to medical devices need to be aware of the FDA’s regulation of medical devices. This requires detailed understanding of the regulations as they exist, as well as the knowledge needed to interpret and apply them into medical devices or software, whatever the case may be.
This is the understanding a webinar from Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will be offering. Thomas E. Colonna, who provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics, medical device software and biotechnology-based products, and holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia, will be the speaker at this webinar.
To gain complete understanding of the FDA’s thinking on medical device regulation and to get a grasp of how to apply it for practical use, please register for this webinar by logging on to FDA’s Regulation of Medical Device Software
At this webinar, Dr. Thomas E. Colonna will offer fundamental understanding of FDA regulation of medical device software. Expectedly, this session will be of immense benefit to professionals at various levels in the field of medical devices and medical device software, such as Compliance Managers, Validation Managers, Regulatory Managers, QC Managers and QA Managers.
At this session, Dr. Colonna will cover the following areas:
o Definition of medical device software
o FDA’s medical device software regulatory scheme
o Software validation
o Level of concern.