Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FDA Proposes Approach for Regulating Certain Mobile Health Care Applications."
Following is an excerpt:
The Food and Drug Administration has proposed an approach for how it will oversee software applications designed for use with smartphones and other mobile devices for health care purposes. Among the examples FDA listed as mobile apps over which it would exercise authority are:
- apps used for displaying, storing, analyzing, or transmitting medical device data, such as remote displays of data from bedside monitors and displays of medical images directly from picture archiving and communication system servers;
- apps used to control medical devices via mobile platforms, such as those that can control the inflation and deflation of a blood pressure cuff and those that can control the flow of insulin on an insulin pump; and
- apps used as part of clinical decision support tools, such as those that provide a questionnaire for collecting patient-specific data and then use the data to compute the prognosis for a particular condition or disease or provide recommendations to clinicians for diagnosing or treating patients.
Attorney Bradley Merrill Thompson told BNA that while the proposal is "fairly narrow," apps developers may be caught off guard by some of the types of applications covered by the guidance. For example, clinical decision support software applications were not necessarily on developers' radar screens as potentially being covered by the FDA guidance. Nevertheless, other categories of apps to which the guidance would apply do not come as surprise, he noted, such as apps that are accessories to already-regulated medical devices.
Thompson, who is a founder of the mHealth Regulatory Coalition, which is drafting guidance documents it will submit to FDA on ways for regulating mobile health products, said that FDA's proposal provides some clarity on oversight issues, but does not answer all the questions the mobile health industry has about FDA regulatory authority over the mobile health products.
For example, he said, FDA did not address questions raised by mobile health product developers about determining the intended use for products that are in the gray area between regulated medical devices and products that clearly do not meet FDA definitions for regulated products. "We want more clarity about intended use."
The guidance also did not address industry concerns about how the accessory rule is applied to products that developers believe should not be regulated in the same category as the medical device to which they are attached, Thompson said. Thompson's group raised issues related to the way FDA applies the accessory rule in a proposed draft of suggestions for FDA it will send to the agency later this year. It noted that in certain situations, FDA regulates a product that is an accessory to a medical device as if it is in the same regulatory classification as the "parent" device.
For some accessories, including some mobile health products, regulating them at the same level as the medical devices with which they are used is "overkill," Thompson said, and FDA could consider "down classifying" them. Thompson further noted that the mHealth Coalition in its draft guidance to FDA will recommend creating—through rulemaking—separate software classifications that better reflect those products than existing medical device classifications.
