FDA request for comments on medical wireless tech

[via MedicalDesign.com] The FDA has issued a guidance document "to assist industry, systems, and service providers, consultants, FDA staff, and others in the design, development, and evaluation of radio frequency (RF) wireless technology in medical devices."

After quickly scanning this document, I see they have one section entitled, "The Least Burdensome Approach." They believe their guidance provides the least burden considering the scientific and legal requirements involved. "However, if you believe an alternative approach would be less burdensome, please contact us so we can consider your point of view."

The another section outlines the scope of this draft guidance:

This draft guidance document addresses issues and concerns pertinent to the safe and effective use of radio frequency (RF) wireless technology in medical devices, including:

• wireless coexistence
• performance
• data integrity
• security
• electromagnetic compatibility (EMC)