In the letter, Sens. Michael Bennet (D-Colo.), Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Mark Warner (D-Va.) and Richard Burr (R-N.C.), ask nine questions about current regulation activities, including how the FDA decides which new devices and software updates warrant regulation, and how new laws and input from the ONC has or will affect regulation.
The senators’ ultimate goal is more transparency in the FDA’s regulatory process for health IT products. “While the FDA’s final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated,” wrote the senators.
More Articles on FDA Regulation:
3 Challenges Faced by the mHealth Industry
NewYork-Presbyterian Selects Winners of Patient Engagement Solutions Contest
Opposition to Bill Limiting FDA Regulation of Health IT Grows
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
