The Food and Drug Administration has released its "Strategic Plan for Regulatory Science," defined as "the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products."

One of eight priority areas is substantially enhancing FDA's information technology infrastructure. Better I.T. will open opportunities to better monitor adverse trends and disease outbreaks; combine data from multiple clinical trials, preclinical work and postmarket studies; evaluate and compare the safety and effectiveness of products; host genomics data; and conduct large scale data- and text-mining for research purposes, according to the agency.

"FDA is in the early stages of constructing the information technology infrastructure necessary for this type of data integration, but full realization of the enormous potential in harnessing these diverse data will require extensive improvements to the current FDA I.T. environment, as well as new analytic approaches and tools," according to the strategic plan. "For example, enhancing FDA's capability to carry out sophisticated data mining activities requires a networking and computational infrastructure that can support an enormous number of simultaneous queries of a large set of indexed data sources."

The strategic plan does not explicitly mention FDA's intention to define and regulate "mobile medical applications" outlined in draft guidance issued in July. Under the guidance, FDA does not intend to regulate mobile computing devices or most applications that run on the devices. Its draft definition of a mobile medical application 'is a mobile app that meets the definition of 'device' in section 201(h) of the Federal Food, Drug and Cosmetic Act and either is used as an accessory to a regulated medical device or transforms a mobile platform into a regulated device."

The FDA will hold a public workshop, or forum, on Sept. 12-13 in Silver Spring, Md., to solicit comment on regulation of mobile medical applications.

 

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