FDA final guidelines for wireless medical devices

Compliance & Regulatory Info Sheet Nr. 3 | Wireless Medical Devices & Connected Healthcare Applications | July 2014
The FDA regulates the marketing of all medical devices
sold or imported in the U.S. It‘s role is to ensure that such
devices are safe and effective for patient use. Recognizing
the increasing use of wireless medical devices, the FDA
recently released final guidelines on this topic that has
been in development for several years. For manufacturers
of medical devices it is extremely important to understand the FDA‘s position on the design,
testing, and use of RF wireless medical devices. Although the guidance is only a recommendation and does not establish legally enforceable responsibilities, it is nonetheless of
considerable importance for device makers.
The following considerations are especially important during the device design and development process:
1. Selection of wireless technology
The optimal wireless technology should be determined through careful analysis of the product
requirements and environmental limitations. Personal health devices often operate in the 2.4GHz
industrial, scientific, and medical (ISM) radio band, which includes Bluetooth, Wi-Fi, and ZigBee.
FDA recommends that manufacturers consider the allocation and availability of radio frequency
bands to be used by the device, address how other existing users of selected radio frequency bands
can impact a device’s operation, and describe methods of mitigating frequency band interference.
To minimize electromagnetic interference with other devices, FDA recommends using the radio
frequency that uses the lowest amount of power.
2. Wireless Quality of Service
The quality of connectivity and ability to ensure a connection should be considered. This includes
the quality of service for a device’s choice of wireless communication, whether by radio frequency,
cellular telephone network, or other medium.
3. Wireless coexistence
The FDA recommends taking into account other wireless technologies and users that might be
expected to be in the vicinity of the wireless medical device. Coexistence will be dependent on
frequency, distance, and time. The designer should consider situations where multiple devices will
be in close proximity, such as in a hospital. Designers should also select a wireless technology that
has coexistence features built in. Bluetooth, for example, uses Adaptive Frequency Hopping (AFH) to
facilitate coexistence with Wi-Fi devices.
4. Security of wireless signals and data
FDA recommends that wireless medical devices use wireless security protection at a level appropriate for the risks presented. The designer should consider FDA‘s draft guidance on premarket submissions for management of cybersecurity in medical devices, which recommends authentication
(password log-in) and encryption.
5. Electromagnetic Compatibility
Compared to other regulatory bodies,
FDA compliance is still considered
as one of the greatest challenges to
obtain market access.
Successful product launches of wireless medical devices in the U.S. require excellent preparation and positive FDA audit results. To ensure
that products will meet the existing wireless
standards and new FDA guidelines, companies
need to be forward thinking in their approach
to safety and performance requirements. Failing
to align with the FDA’s new focus can result in
costly delays. This is a real risk for those products that do not properly implement wireless
technology or whose systems aren’t tested rigorously. If this happens, the cost to a company’s
reputation and brand can far outweigh the cost
of proper design and testing.
To ensure a fast approval process, the FDA
recommends a Premarket Submission that include the information, as approporate, for your
specific device.
Avoid losing time and money!
Contact CETECOM if you intend to import your
medical device with wireless application in
the U.S. : with our long-term experience and
spezialized know-how we can streamline the
testing & certification process and help you to
ensure that your pre-market submission fulfills
all FDA requirements! As a specialist in wireless technologies we can assist you with engineering services, compliance testing including
the latest EMC and coexistance requirements,
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The guidance recommends that EMC should be an integral part of the development, design, testing,
and performance. Manufacturers should address applicable standards and regulations regarding
the potential for a wireless medical device to interfere with other equipment. Although standards
such as IEC 60601-1-2: 3rd Edition are recognized by FDA, they do not adequately address electromagnetic disturbances. Therefore FDA recommends that electromagnetic immunity testing be
addressed in addition to meeting such standards. Early 2014 IEC published IEC 60601-1-2: 4th Edition while implementing considerably increased levels for radiated immunity. For more information
on this topic consult our Medical Engineering info sheet on Wireless Coexistence.
FCC - background
6. Proper setup and operation
FDA - background
Apropriate information, including a warning that other equipment could interfere with the medical
device system, should be provided to users of the device to help assure proper setup, configuration
and performance of the wireless medical device.
7. Maintenance
FDA recommends that the manufacturers continue to manage the risks associated with the use of
wireless technology for the entire life cycle of the device. Procedures for implementing corrective
and preventative action must include analyses of possible trends in nonconformance information
and complaints.
=> Click here to download the final FDA guideline on Wireless Medical Devices
Every wireless medical device - whether implanted or worn on the body - falls within the FCC’s authority to manage the electromagnetic spectrum.
Under FCC rules, wireless devices must be tested
for conformance to various technical standards
and authorized before they may be imported, marketed or operated in the U.S.
The FDA regulates the marketing of all medical
devices sold or imported in the U.S. Unlike the
FCC, which focuses on the interference potential
of wireless devices, the FDA’s role is to ensure that
such devices are safe and effective for patient use.
Recognizing the importance of the development
of wireless and mobile medical devices and applications FCC and FDA have signed a ‚MOU‘ to
closely colloborate in order to find solutions for a
regulatory framework that encourages innovation.
© CETECOM Group 2014 | Contact: [email protected] | www.cetecom.com

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