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 Group Urges FDA to Publish Final Guidance."
Following is an excerpt:
Some mHealth advocates are getting impatient with the U.S. Food and Drug Administration. The FDA released its preliminary guidelines for the regulation of mobile medical apps in late 2011, and since then the mHealth world has been awaiting the government agency's final document.
Bradley Merrill Thompson would like them to speed things up a bit. Thompson, an attorney with the Washington-based law office of Epstein Becker & Green and member of the mHealth Regulatory Coalition, has fired off a letter to Health and Human Services Secretary Kathleen Sebelius asking that the final document be published "as soon as reasonably possible."
"The MRC believes the timely release of the final guidance will benefit industry, stimulate investment, help ensure patient safety and is consistent with the views expressed by Congress and the desires of the broader mHealth community," Merrill wrote in the letter, sent on June 21. The guidance, he added, "is needed by industry and will help unlock investment in the mHealth market. Many investors and companies are reluctant to invest significant time and money in mHealth technologies until the regulatory framework is clear."