Matthew Bodo For the device to send data? For the device to receive data? Both?

It may be less of an issue from a device perspective and more of an issue with regional communications agencies (e.g. FCC in US) to ensure you don't choose bandwidth shared with things like garage door openers.

Beyond that, I'd speculate that you'd have to comply with the maximum allowable level of RF radiation a body is expected to absorb over a given period of time, and try not to exceed that.

Either way, check with Apollo Endosurgery in Texas. I may be mistaken, but they bought all of Allergan's LAP-BAND related product and IP. Part of that may have been the RF controlled band adjuster. I honestly forget what we called it at the time. (It was engineered out of Switzerland, EndoArt SA I believe?)

Good luck.

FDA guidance document "Guidance for Industry and FDA Staff Radio-Frequency Wireless Technology in Medical Devices, August 14, 2013" references ISO technical report "TR 21730, Health Informatics – Use of mobile wireless communications and computing technology in healthcare facilities – Recommendations for the management of unintentional electromagnetic interference with medical devices (ISO/TR 21730: 2007(E)". Have you seen that?

azza ghodhbani Thank you Matthew, actually it is for both receiving and sending data.
Where can I find information about the maximum allowable level of RF? This would be helpful.

azza ghodhbani Thank you Artie, I will have a look at this guidance.

Paul Baim While you're worrying about RF, you should also be worrying about the data. Broadcasting data is inherently less secure than transmitting it over a hard wire. How are you protecting the data end-to-end? You are also opening up a new attack surface to the bad guys. Worry about that too.

Tilo Borchardt For the EU market you have to follow the R&TTE guideline beside MDD for medical devices.

See here for more information and related standards:
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/rtte/index_en.htm

e. g. EN 300 328 V1.9.1:
Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive

azza ghodhbani THank you Paul and Tilo

I feel that beyond compliance testing as per RTTE directive , interoperability testing as applicable to the chosen wireless technology must be looked at for using word marks and logos.

Agreeing with Paul. Once you've figured out the RF part, be sure that the protocol built on top is secure. Wireless is inherently less secure, and more prone to interference than wired communications.

Here is an FDA guideline on cyber security: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm356190.pdf

Paul Baim Thanks, Daniel. The guideline is typically vague although it does give a small bit of usable advice and links to more documents that probably provide more useful content.

Tilo Borchardt The use of FDA "Recognized Standards" is not mandatory:
"Conformance with recognized consensus standards is strictly voluntary for a medical device manufacturer. A manufacturer may choose to conform to applicable recognized standards or may choose to address relevant issues in another manner." (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077274.htm#3a2)

Hi,

As I said "usually means a must". You can select another means to meet requirements but, again as said, it may turn to close to impossible.

Caption from the cited link:
" In 510(k)s, information on conformance with recognized consensus standards may help establish the substantial equivalence of a new device to a legally marketed predicate device. This information may be used to show that the new device is as safe and effective as the predicate in the areas covered by the standards. Moreover, if any premarket submission contains a declaration of conformity to the recognized consensus standards, as discussed below, this declaration should, in many cases, eliminate the need to review the actual test data for those aspects of the device addressed by the standards."

So in short: You can do it on your own, but doing so, you have to prove with actual evidence (test data e.a.), that final product is equally good or better than the standard produces.

Not so easy. I'm sure there are open ears to hear if someone has really done it on their own omitting recognized standard and got 510(k). And in this I think the interest is common regardless of the standard.

New regulations - FDA just recently added 12 new standards to their "Recognized Standards" list to control communication to and from medical devices, mainly for home use like Blood Pressure meters e.a.: http://standards.ieee.org/news/2013/ieee_11073_medical-device_communication.html.

For new 510(k) applications "Recognized Standard" usually means a must, no proprietary communications anymore. For manufacturers, not good. For consumers, brilliant: The meter will communicate with any standards-compliant hub (like smart phone app), from any vendor.

Standards fulfill also FDA's Cyber Security requirements, so it might become close to impossible to go around with other means.

* only exception to the rule are old meters on the market already, and their communications. 510(k) upgrades are allowed.

In EU those same standards are adopted as "National Standards", still unclear are they mandatory or just recommended. However for Cyber Security again, why try to invent something equally good (and hope it passes CE exam, as you have to prove it) as these standards offer adopted solution.