Technology does not limit or inhibit the regulatory procedure but enhance and streamline it so that information/forms can be submitted digitally so that there is effective and expedited communication between the FDA and the company. All data, which includes health records, are kept on the cloud so this allows for easier communication of data but also comes with its consequences. 

Telemedicine has been growing recently after COVID so technology has facilitated patient engagement and data collection. This has been efficient for patients since there are some who have limited mobility and non-urgent questions. Thus, the FDA has ensured that devices controlled telepathically collects and manages sensitive and confidential data safely. 

Concerns like cybersecurity arises especially for devices that have electronic-related components in them. Consequences of not regulating could have effects on patient safety and data breached but the FDA has has been actively addressing cybersecurity concerns related to medical devices and digital health technologies.

Thus, even though technology has streamlined medical devices, regulatory agencies need to consider the cybersecurity risks that arise from their devices and protect patient safety and data at the same time. 

I agree that a lot of places uses technology, but there are a lot of places that still rely on paper based systems. As a result, I think we need to have a roll over period to get everyone to electronic, before you revise current systems to be more friendly with electronic stuff. Either that, or you duel path it and push people to go electronic and revise current systems. 

It is hard to say if the old way of doing things could be the best as we may never know what could be the best. If something works, and works extremely well, then why change it? I also feel like time is a big factor when developing and introducing new ideas. I think AI is a big contender for this topic as people like to use it as it saves time when getting something that a person wants. Many of you know the saying, 'time is money' which is a very true statement, the less time something takes, the more money is gained for a shorter amount of time. With regulatory procedures, I think people try to regulate things as fast as they can, this is where technology can help these procedures.

In my opinion, technology has the potential to improve regulatory practices in industry in a multitude of ways. A few ways that technology can improve regulatory practices include streamlining processes, automated data analysis, and real time analytics. Automation tools and software can streamline documentation and reporting processes, making it easier for companies to comply with regulations. This will save time on both the company's end and the regulatory bodies. Data analysis can also be greatly improved by technology, allowing compliance issues to quickly be identified and isolated using continuous analysis. The main pitfalls that I can see with implementing technology into regulatory procedures are the complexity of the pre-existing frameworks and data security. The current regulatory procedures are dependent on the existing structure. Adding in technology will undoubtedly come with many kinks in the beginning, but once these issues are addressed it will be worth it for the improved efficiency that comes with it. Data security is also an issue to consider when moving towards more technology-based procedures because with everything being in a digital form, it is more exposed to being leaked.  

I think that newer technology facilitates more efficient Regulatory practices, while also raising more questions. Documents and meetings could be submitted and held virtually, which saves time and costs on both ends of the company and FDA. Newer technology applied to devices, such as robotic and virtually operated surgery might be seen as major changes from previous surgical products, and may require to be classified as Class 3, and fill out a PMA before completing clinical trials. This also raises some questions such as what are the safety limitations of the use of these advanced technologies, and under technological failure, how would operating room procedures prevent power or internet connection loss, and provide an  emergency operating plan for such failure? I wonder if the FDA considers that in the approval process of such technologies.