DOS 752 - Week 6 Activity
Research your facility's CQI Program. What are the components of the program? Who is the team in your department? What processes are evaluated? What are the components of the program within your department? How does QA fit into this CQI program?
If you feel it's lacking (meaning they only do QA), how can this be implemented or improved at the site?
Post: 510(k) Flow Chart
The U.S. Food and Drug Administration (FDA) is a regulatory organization that oversees the safety of food, cosmetics, pharmaceuticals, and medical devices.1 The FDA's role in overseeing medical devices is not nearly as widely known as the roles that are part of the organization's name, but it is just as important. The FDA does not perform its own testing and validation of every medical device that every company wants to bring to market; instead it relies on companies performing and presenting their own research to demonstrate the safety of the product.2
Companies seeking to market a new product must file a 510(k) premarket notification with the FDA, and the filing must be fully evaluated before the product can be advertised. One way that companies can bring products to market more quickly is to demonstrate substantial equivalence (SE) to other products that are already on the market. Depending on the level of similarity, different levels of scrutiny may be required. The FDA has provided a flow chart that helps companies determine which form of 510(k) filing to submit, as seen here.
Figure 1. FDA 510(k) filing method flow chart.
Once the filing has been received, the FDA evaluates it and determines whether is substantially equivalent (SE) or not substantially equivalent (NSE). If a product is declared NSE, another much more onerous process must be followed to prove that the product is safe. This may involve clinical trials and substantial testing that can take months or years to complete.
In my last career working for MIM Software, I was able to learn a little bit about the 510(k) process when MIM developed the first ever diagnostic-quality radiology application for a mobile device. This was back in 2008, when Apple released the iPhone Software Developers Toolkit that allowed third parties to write applications for the iPhone. This was a revolutionary step, because up until that time, all third party iPhone tools had to be implemented as web pages. Being able to take advantage of the local storage on the device and the speed of local processing made it possible to write applications with rich user experiences such navigating through large radiology images with windowing and leveling of 12 or more bit grayscale.
MIM tried to show equivalence to its CD viewer product which was already 510(k) cleared, but it ran into problems because of the new hardware platform. Even though the concept was identical, smart phones as we now know them had only been around for a year at that point and it was an uphill battle to show that a telephone can also be a powerful device with a high quality screen and many of the capabilities of a traditional computer. It took 3 attempts and 2.5 years to get 510(k) clearance, during which time the software could not be distributed or advertised.
Once MIM finally received its 510(k) clearance, competitors were able to follow quickly because they could point to MIM's application as a substantially equivalent device. When developing a new feature for an existing piece of software, the process is much simpler, because the Special 510(k) for Device Modications can be used. Once a product category is well established, an Abbreviated 510(k) can be used if a new product follows the recognized standard. Even though these processes are complex and time consuming, they are valuable in ensuring that medical products aren't sold or marketed without scrutiny.
- What we do. US Food and Drug Administration Website. http://www.fda.gov/AboutFDA/WhatWeDo/default.htm. Updated 12/7/2015. Accessed 12/9/2015.
- 510(k) submission methods. US Food and Drug Administration Website. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134034.htm. Updated August 21, 2014. Accessed December 9, 2015.