Clarify regulatory requirements and the approval process for converged communications and health care devices

Recommendation #102

Status: In progress

The Federal Communications Commission and the Food and Drug Administration (FDA) should clarify regulatory requirements and the approval process for converged communications and health care devices.

As part of this process, the FCC and the FDA should seek formal public input within the next 120 days and hold a workshop with representatives from industry and other relevant stakeholders to examine real case studies.

Through this joint, transparent process the agencies should seek to answer questions such as: "Which components of a health solution present risk that must be regulated?" "How can the process for introducing products to the market be improved?" and "What are the characteristics needed for 'medical-grade' wireless?" After public input is received, the agencies should offer joint guidance to address these and other relevant questions.