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 Update to mHealth Rule."
Following is an excerpt:
Appearing on March 25 in the Federal Register, the 52-page document basically clarifies the process by which the FDA would classify medical devices — an action required under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which amended sections of the earlier Federal Food, Drug and Cosmetic (FD&C) Act. That amendment enabled the FDA to reclassify medical devices by administrative order instead of regulation.
According to the proposed rule, the FDA is offering "these revisions to update its regulations to reflect these and other changes, and to ensure classification of devices in the lowest regulatory class consistent with the protection of the public health and the statutory scheme for device regulation." ...
In published reports, Bradley Merrill Thompson, a Washington D.C. attorney and general counsel for the mHealth Regulatory Coalition, hailed the FDA's proposed rule, saying current mHealth products "do not fit squarely into the old classification system." He added that the FDA, through this new action, could "do a better job of keeping up with these important new technologies, providing clear guidance for the new categories of technology being developed."
