Congress members grill FDA, FCC on wireless med device regulations

Rep. Marsha Blackburn (R-Tenn.), along with five Congressional colleagues, has sent a letter to the Office of the National Coordinator for Health IT (ONC), the Federal Communications Commission (FCC) and the FDA imploring the agencies to clarify who oversees each agency’s policy development (including regulations, guidance, etc.) for wireless health devices and their supporting infrastructure, as well as how the policy measures are coordinated among the agencies and the ONC.

“[Wireless medical devices] increasingly cross two regulatory structures—the FCC and FDA. It is critical the two agencies act in concert to provide regulatory predictability, consistency and swiftness so needed innovation in wireless medical technology may thrive,” wrote Blackburn et al.

The authors noted that between 2010 and 2011, the number of medical applications available in the iTunes App Store subject to FDA evaluation under increased by 250 percent and they are concerned applying a complex regulatory framework could inhibit future growth and innovation. Therefore, they requested an update on the agencies’ activities on its coordination in relation to regulating wireless medical devices.

They posed questions, including:

• What primary activities related to wireless health devices are underway at each agency? Please include efforts that are conducted independently and jointly, as well as those in conjunction with ONC.
• We envision device to EHR to EHR module interoperability in the near future. What communication or coordination activities have taken place between the FDA, FCC and ONC and what plans do your agencies have to coordinate regulatory requirements across the agencies?
• What efforts have been undertaken or are being planned to better leverage staff expertise relative to wireless medical devices and supporting infrastructure across the agencies?
• Both the FDA and FCC have publicly discussed efforts to make possible wireless “testbeds” for the important purpose of better understanding how wireless health devices co-exist in the healthcare setting and advancing medical device interoperability. Please provide an update on these efforts, including each agency’s role in the development of wireless “testbeds” and the promotion of interoperability.
• How are the FDA and FCC coordinating review processes for devices that may be subject to regulation by each agency?

Blackburn and colleagues requested a unified response within 14 days of the letter, dated April 3.