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 Legislation Clears House, Moves Closer to Final Senate Approval."
Following is an excerpt:
The Senate moved closer to final approval of a bill (S. 3187) to reauthorize the user fees that medical device companies pay to support the work of the Food and Drug Administration. ?...
The bill also would require the Department of Health and Human Services to produce a report with input from FDA, the Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission on an "appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication."
Commenting on the provision, Bradley Merrill Thompson, of Epstein Becker Green, in Washington, said "the mobile health industry avoided a big stumbling block with the help of Congress."
"Over the last several weeks, a debate has been raging on Capitol Hill regarding whether Congress should step in and slow down the FDA process for clarifying the scope of the agency's regulation of mobile apps," he said. "On the one side, those who oppose FDA regulation were seeking a delay in the FDA guidance, pending a substantial review by a variety of stakeholders including other agencies and the Congress itself. On the other side, those who acknowledge that FDA has a legitimate role to play wanted to avoid any delay, in the desire to get needed clarity around the scope of FDA regulation so that industry and investors could move forward."
Thompson said the provision does "not prevent FDA from finalizing its guidance in the meantime," and "many in industry breathed a sigh of relief."
Additionally, Thompson said, HHS may convene a working group to aid in the development of the report with stakeholders from outside government, including venture capital investors, health information technology vendors, and small business owners.
