| 2006D-0504 | Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices | |||||||||||||||||||||||
| FDA Comment Number : | EC4 | |||||||||||||||||||||||
| Submitter : | Dr. George Titus | Date & Time: | 04/02/2007 05:04:00 | |||||||||||||||||||||
| Organization : | LifeSync Corporation | |||||||||||||||||||||||
| Category : | Device Industry | |||||||||||||||||||||||
| Issue Areas/Comments | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| LifeSync Corporation is pleased to support all the recommendations in the Draft Guidance for Industry and FDA Staff - Radio Frequency Wireless Technology in Medical Devices. We find the draft to be very well organized and completely relevant. As a leader in the use of wireless technology for ECG and respiration, LifeSync(R) products are routinely checked for wireless coexistence, performance, data integrity, security and electromagnetic compatibility. We fully support these recommendations as they apply to our current and future products, and also to other companies interested in wireless technologies for medical uses.
Thank you for the opportunity to comment on a draft document that is well balanced and establishes the appropriate expectations of us in the field. Well done! Best regards, George R. Titus, PhD Sr. Vice President LifeSync Corporation | ||||||||||||||||||||||||