Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was featured in an article titled “FDA Issues Final Guidance on Mobile Medical Apps.”
Following is an excerpt:
A bit more than two years after releasing their draft guidance, FDA has released the final guidance (pdf) on mobile medical apps (FDA press release). FDA also put up a new page on their web site with information on mobile medical apps.
In this final guidance, FDA has chosen to use two factors to distinguish between mobile medical apps that are low risk that they do not intend to regulate, and higher risk apps that will be regulated. FDA will regulate those mobile medical apps intended:
- to be used as an accessory to a regulated medical device; or
- to transform a mobile platform into a regulated medical device. ?…
This guidance process was not without some controversy. One group, lead by Brad Thompson and the mHealth Regulatory Coalition, was pushing for a quick publication of the final guidance in an effort to end the existing ambiguities around regulating mobile medical apps. ?…
Thompson replied, noting that waiting for legislation as suggested by the “delay guidance” group would take months or years, and the market would benefit from a reduction of ambiguity regarding mobile medical apps now.