An Introduction to Medical Technology Evaluation
By William Huang
Let’s say you invent a breakthrough medical device and would like to put your device onto the market? In biomedical research, although the development of new technology itself is extremely important, the evaluation of these devices is equally important in order to bring this technology onto the market, such as acquiring FDA approval. So how exactly should you go about this process?
So as a brief recap, what is a medical device? The characteristics of a medical device are specified in the Federal Food, Drug, and Cosmetic act. Now the characteristics of a medical device are different from those of a pharmaceutical, as medical devices are not chemical compounds. A medical device is defined as an instrument, apparatus, machine contrivance, in vitro reagent, or other similar or related article including a component part, or accessory. Medical devices are extremely helpful in the diagnosis, treatment, or cure of a disease.
There are two common methods for obtaining FDA approval for a medical device, each differing in their ways, from pharmaceutical regulation to approval. The first way for the medical device is known as premarket notification, an approach used for more established products. It requires a 510(k) submission. 510k submissions must show that the product is substantially equivalent to an existing legally marketed technology. Essentially, these technologies have a proven track record in the marketplace and only represent an incremental improvement to the existing device. For example, if it's a bandage, maybe it has a different type of adhesive that sticks just well that can be removed more easily than current adhesives. The second way is the premarket approval application and these are for breakthrough technologies or new and innovative devices.
There’s three general types of medical devices. Class 1 are general controls and these are products with the lowest risk and are not subject to premarket review. They account for almost half of medical devices, including bandages and rubber gloves. The second class of drugs are products that pose either a low or moderate risk. These devices can’t assure safety and effectiveness. This makes up over 40 percent of the remaining amount of medical devices. Class 2 requires certain labeling requirements and performance standards, with devices like powered wheelchairs, pregnancy tests, or hip or knee joints. Finally, the third class requires premarket approval and these technologies are considered high-risk and breakthrough. Therefore, Class 3 device approval requirements are more detailed, requiring extensive preclinical and clinical data. After all the data is collected and submitted by the manufacturer, the FDA reviews all the data (usually takes a year), as well as any other information on labeling and manufacturing processes, as part of the application. Examples of products subject to this review include artificial heart valves, coronary stents, novel diagnostic tests, or diagnostic tests that have not been on the market before.
Citations
https://www.perforce.com/blog/alm/how-get-fda-approval-medical-devices
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-application-contents
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