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 “mHealth Industry Groups Plan to Monitor FDA Enforcement, Software Regs.”
Following is an excerpt:
An association of small- and mid-size mobile medical application developers said it expects stakeholders will have to continue discussions with FDA about how the agency plans to regulate clinical decision support software despite assurances from FDA’s top device official that the issue will be addressed in a report submitted to Congress in January. The topic was absent from final guidance on mobile medical apps released this week and the Association for Competitive Technology said it anticipates questions about these applications may not be adequately resolved by the report. ?…
FDA’s transition from guidance development to the enforcement phase for mobile medical apps will also be a key issue for stakeholders, said Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition. He said manufacturers of higher risk apps that will be regulated by FDA and that were not already in compliance will now have to develop a plan for doing that. Shuren said during a stakeholder call on the guidance this week that the agency would be willing to help companies come into compliance.
“He explained that they do not have an ambition to collect scalps ?… but rather would like to work with companies that find themselves within the scope of FDA regulation,” Thompson said. “Thus, if, for example, a company already has an app on the market that is within FDA regulation but the company has not taken steps to comply, it is my impression that FDA will want to work with that company over a period of time to allow them to come in compliance, perhaps without requiring them to exit the market.”
At the same time, Thompson said he did not detect a lack of firmness on FDA’s part and it is clear the agency believes high-risk apps need FDA regulation.