Citing the explosive growth of wireless medical devices and smartphone applications, six House Republicans have written the heads of the FDA and the Federal Communications Commission (FCC) to urge acceleration of regulatory processes and request a detailed progress report.
After expressing appreciation for recent developments involving the cooperation of the agencies—the two signed a memorandum of understanding (MOU), issued a joint statement and held an exploratory public meeting—the representatives warned against bogging down in the face of rapidly evolving technologies. They gave as examples mobile cardiac outpatient telemetry that uses wireless skin sensors, real-time glucose monitors that wirelessly transmit data to wearable insulin pumps and a 250 percent surge in medical apps available in the iTunes store over the past two years.
“We are concerned that applying a complex regulatory framework could inhibit future growth and innovation in this promising market and could preclude tools that help patients better manage their care and allow the health system, as a whole, [to] reduce costs and improve quality,” they wrote in the letter, which was dated April 3 and addressed to FDA commissioner Margaret Hamburg and FCC chairman Julius Genachowski. “More so, we fear that despite initial enthusiasm, the daily work of expeditiously evaluating these valuable solutions has slowed at a time when they are most needed.”
The six—Marsha Blackburn of Tennessee, Joseph Pitts of Pennsylvania, Greg Walden of Oregon, Brian Bilbray of California, Michael Burgess, MD, of Texas and Phil Gingrey, MD, of Georgia—asked for a “unified response” within two weeks to nine questions, including:
- “What specific joint actions have your agencies undertaken to date to implement the MOU? Please include public meetings, inter-agency meetings, data sharing, publication of and/or consultation on guidance documents and reports and other activities relevant to implementation of the MOU.”
- “How are FDA and FCC coordinating review processes for devices that may be subject to regulation by each agency? Please include mechanisms that are in place or are being planned to prepare for the increasing application of wireless technologies in medical device innovation.”
- “We envision device to EHR or EHR module interoperability in the near future. What communication or coordination activities have taken place between FDA, FCC and ONC [the Office of the National Coordinator for Health IT] and what plans do your agencies have to coordinate regulatory requirements across the agencies?”
The representatives, all members of the House Energy & Commerce Committee, also asked the agency heads to provide a single point of contact with whom they might engage to support coordinated FDA/FCC efforts going forward.
As of press time, the agencies had not yet issued a response to the letter.