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 Device Official Defends mHealth Oversight Amid Lawmakers' Concerns."
Following is an excerpt:
An FDA device official Thursday (March 21) tried to quell House Republicans' concerns about how the agency would regulate mobile medical apps by touting its long history of regulating medical devices, including mobile medical devices used as software platforms. Christy Foreman, director of the device center's Office of Device Evaluation, told the House Energy and Commerce Committee's oversight panel that FDA plans to finalize long-awaited guidance on mobile apps by the end of the fiscal year. FDA will also convene its first health information technology working group meeting by the end of April, another agency official recently said.
During three days of committee hearings, Republicans raised questions about regulation of health information technology and whether smartphones and tablets would be subject to a 2.3 percent medical device tax under the Affordable Care Act based on language in an FDA draft guidance on mHealth. ?...
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, said during Tuesday's hearing that he believed FDA has delayed issuing the guidance because the agency is trying to create definitive answers for an industry that changes on almost a daily basis and suggested instead that the agency issue final guidance that would be updated periodically.
Yet, Thompson added that he felt FDA was best-equipped to oversee the products.
"We favor sticking with FDA as both the regulator for the traditional device industry and the less traditional," he said. "There was a rumor circulating that people wanted to move mobile health regulation away from FDA. We don't support that. This is a new technology. We're all learning the technology, but they have the public health knowledge in order to do this and to do it right."
