FDA proposes freeing apps, software from burden of medical device definition

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The changes will affect existing guidance on general wellness products and mobile medical applications.

The FDA is set to exempt certain types of software from regulatory oversight as it reconsiders its approach to products on the fringes of the medical device sector.

Officials at the agency set out their plans in three guidance documents: two draft, one final and an accompanying statement from Commissioner Scott Gottlieb, M.D. The documents affect regulation of clinical decision support (CDS) software, digital health technologies and Software as a Medical Device (SaMD).

In the draft guidance on CDS, the FDA proposes no longer defining certain forms of the software as a medical device. That would free companies to develop software that helps doctors diagnose diseases without facing FDA scrutiny, provided they didn’t cross the new line put in place by the agency. 

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The FDA is putting tools that allow doctors to review the basis for their recommendations on the unregulated side of the line. In contrast, products that perform the diagnosis independently of the doctor will remain within the purview of the FDA. 

“The FDA will continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act,” Gottlieb said in a statement.

Gottlieb’s focus on aligning FDA guidance with the Cures Act while freeing devices unlikely to affect patient safety from regulation is evident in the second draft text. That document proposes changes to the FDA’s position on medical software. The changes will affect existing guidance on general wellness products and mobile medical applications.

Previously, the FDA said it would exercise “enforcement discretion” to avoid over-regulating apps that fall within the definition of a medical device but pose a low risk to the public. Now, the agency is planning to more clearly mark the boundary by stating certain types of products do not meet its definition of medical device.