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 Guidance on Mobile Medical Apps Could Come in Early Fall, Attorney Says."
Following is an excerpt:
The Food and Drug Administration could issue as early as October final guidance to mobile medical applications developers on how it will oversee software designed to operate on smartphones and other mobile devices for health care purposes, an attorney who follows FDA oversight of mobile health products said Aug. 30.
Bradley Merrill Thompson, with Epstein Becker & Green PC in Washington, said he predicts FDA will release a final version of the long-awaited guidance before the November elections, but will leave some key issues surrounding mobile applications oversight unresolved.
Thompson spoke during the FDAnews Medical Device Mobile Apps Virtual Conference.
He said FDA appears to be "trying earnestly" to limit enforcement actions that involve low-risk products and focus its oversight efforts on applications that provide patient-specific outputs used to make clinical decisions. ?...
Thompson told the FDAnews conference that he expects final guidance to be issued but without resolving questions raised in the industry about how FDA will define "wellness" (with wellness products falling outside the scope of regulation) and "health" for the purposes of determining which mobile applications products will fall under oversight purview and how FDA will apply the medical device accessory rule to mobile applications oversight.
He said he was hopeful, however, that FDA would in the final guidance narrow its definition of clinical decision software to include only those products that had the potential to pose true risks to patients, such as those used in the treatment and care of patients with diseases such as cancer.
