This post was written by Judy Harris, Amy Mushahwar and Areta Kupchyk.
The Federal Communications Commission (FCC) just announced that, as part of its implementation of the recently released National Broadband Plan and the Plan’s recommendation to use the power of broadband to improve healthcare, the FCC and the Food and Drug Administration (FDA) are going to be holding a public meeting on July 26 and 27, 2010, to discuss regulatory issues arising from the convergence of wireless technology and healthcare devices. The meeting is formally entitled: “Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and Information Processes.” The purpose of this meeting is, among other things, to discuss ways to promote investment and innovation in health technology by streamlining government processes.
To help develop an agenda for this important meeting, the FDA and the FCC are seeking input from, among others, the medical and device manufacturing industries, practitioners, and other stakeholders and users of medical technology on a number of questions regarding regulatory challenges and safety of patients and other users of medical devices that include radio elements and of systems that can be tied into broadband communications networks. The information gathered will be used to enhance coordination between the FDA and the FCC for healthcare devices and applications and clarify the respective areas of expertise and jurisdiction between the agencies. The solicitation of this information is intended to simplify and expedite the introduction of new medical technologies and devices.
To this end, the FCC and the FDA have released a list of specific topics on which they are seeking input. Those topics are included in the Public Notice.
Commenters, however, are not limited to addressing the specific topics set forth, but rather should feel free to raise any issue of interest or concern. The details of the two-day meeting at the end of July will be shaped by the comments received. After those comments are reviewed, a final agenda for the meeting will be posted on the Internet.
Comments are due June 25, so time is of the essence
Finally, the meeting will be open to the public and there will be an opportunity for interested parties to make oral presentations during any of the open comment sessions. Preregistration to attend the meeting is desirable and required should you wish to speak. The registration deadline is July 19th.
Please contact Judy Harris, Amy Mushahwar or Areta Kupchyk if you would like further information regarding these issues.