The guidance provides insight into FDA’s expectations with respect to premarket submissions and design protocols of wireless medical devices and sets a standard for a manufacturer’s response to reports of complaints or problems with such products.
Given the proliferation of medical devices using wireless technology—and the accompanying risks regarding security, performance, compatibility, and other challenges—FDA in August 2013 issued a guidance for radio frequency wireless technology in medical devices.
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Although the guidance states that it is only a recommendation and does not establish legally enforceable responsibilities, it is nonetheless useful for device makers. Guidances provide FDA’s interpretation of existing regulations and are frequently referenced by attorneys and courts in lawsuits seeking to establish that a manufacturer was negligent for failing to follow FDA statements in a guidance. Review of the wireless technology guidance, therefore, is critical for companies whose devices use such technology.
There are two parts to the guidance: One contains consideration for design, testing, and use of wireless technology and the other gives recommendations for premarket submissions for devices that incorporate radio frequency wireless technology.
The first part of the guidance sets forth recommendations and interpretations in connection with FDA regulations 21 CFR 820.30, which regulates the design of a medical device, and 21 CFR 820.100, which regulates procedures for corrective and preventive actions.
Per 21 CFR 820.30, manufacturers are required to establish and maintain procedures to ensure design requirements are met. These design procedures include addressing design reviews, conflicting design requirements, and procedures for design validation to confirm the devices conform to intended uses and needs.
As part of design validation, the guidance requires manufacturers to include risk analysis of wireless communications and control functions. Six factors should be addressed when dealing with design controls:
The guidance also recommends that manufacturers continue to manage wireless technology risks for the entire life cycle of the device. Procedures for implementing corrective and preventive action must include analyses for possible trends seen from complaints or reports of failures. If a failure or malfunction of a wireless function is identified, the cause must be investigated and action must be taken to correct the problem and prevent its recurrence. Measures include analyzing production and repair records and verifying any corrective and preventative action to ensure that such action is effective. This recommendation may be in reaction to well-publicized accounts of a hacker who was able to hack into his own wireless medical device and who was purportedly ignored by manufacturers.
The second part of the guidance recommends that manufacturers preparing premarket submissions for wireless medical devices include these four subjects:
The guidance provides not only insight into the FDA’s expectations with respect to premarket submissions and design protocols of wireless medical devices, but sets a standard for a manufacturer’s response to reports of complaints or problems with such products. Not only must the risks of wireless functions in new medical devices be foreseen and anticipated, but risks in existing wireless medical devices that may not have been present when the device was designed must also be investigated, and the process must be documented. This also has ramifications for potential liability exposure in future litigation, as manufacturers that fail to heed this guidance may be deemed to have not acted properly in either the design process or the postmarket surveillance process.
Michael D. Shalhoub is cochair of the life sciences and medical devices practice group at the law firm Goldberg Segalla. He has more than 30 years of experience defending manufacturers of health-related and personal care products. Reach him at email@example.com.
Soo-young Chang is an attorney in Goldberg Segalla’s cyber risk and social media practice group. He represents medical device manufacturers in product liability litigation and regulatory matters and has authored and presented on the subject of data security risk. E-mail him at firstname.lastname@example.org.
[image courtesy of David Castillo Dominici/FREEDIGITALPHOTOS.NET]