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| BIOTRONIK submits the following comments to FDA's Draft Guidance for Industry and FDA Staff concerning Radio Frequency Wireless Technology in Medical Devices. BIOTRONIK feels that this draft guidance is very limited in its usefulness because it provides general guidelines for RF wireless portions of medical devices; however it does not provide details necessary for determining what type of features and functions can be utilized in medical devices. The guidance document is not written in collaboration with regulations of the Federal Communications Commission (FCC) and is therefore contradictory or missing several important elements. There is no reference to the MICS frequency band (CFR 47 Part 95) that is specifically designed for medical communications with this type of device. FDA attempts to limit device output power by stating 'FDA recommends wireless medical devices limit their RF output to the lowest power necessary to reliably accomplish their intended functions.' However, this provides very little direction to the medical device industry. BIOTRONIK believes that use of existing FCC guidelines and specifications will ensure that many of the potential issues listed by FDA will be appropriately addressed and will not cause significant risks to patients. In addition, BIOTRONIK strongly believes that many of the additional labeling requirements included in this draft guidance document are overly burdensome and useless to the physician users of medical devices. The requirements to summary performance, EMC and coexistence testing in the technical manuals for devices is a significant increase in the amount of information now placed in this labeling. While we agree that this information is useful to FDA and should be included in premarket applications, placing it in the physician labeling is unnecessary. Reference to International Standards and test specifications in the labeling also provides little or no benefit to the ultimate users of medical devices. Therefore, BIOTRONIK submits the attached comments on the draft guidance document. See Attachment. Jon Brumbaugh
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