The Growth of the Health IT Sector and the Need for More Robust FDA Regulation
By Adam
Nurep
Originally posted on December 21, 2012
Over the last six years, there has been significant growth in the health technology sector (e.g. mobile medical apps), driven by advances in technology and an increase in venture capital (VC) funding. VCs have been lured into the space due to the perception of high returns on investment within shorter timeframes versus their traditional life science funds. The significant growth in this market has driven the need for increased scrutiny from the FDA in how these products should be regulated.
The FDA has the authority to regulate software if it falls within the broad definition of a “device”. It has further segmented medical devices into three classes; Class I, Class II and Class III. Class I devices don’t require FDA regulatory filing (i.e., 510(K), Premarket Approval Application (PMA)) whereas Class II requires 510(K) and Class III devices require a PMA. The class to which a device is assigned determines the type of premarketing submission/application required for FDA clearance, prior to product launch.
While the FDA has had policies in place for many years regarding the regulation of software/computer products, it has historically taken the position not to enforce the regulation unless the product interfaces directly with a medical device. In cases such as these, products have then been subjected to regulation as if they were a medical device. This caused problems for the manufacturers of these devices as there was no structured classification system based on a risk assessment, making it difficult to predict whether a device would end up being a Class I, II or III medical device. Furthermore, the rapid adoption of mobile technology within healthcare meant that there was a pressing need to develop specific guidelines around the regulation of these products also (out of the 14,558 medical apps currently available, only 75 have received clearance from the FDA).
The entire article is here.
