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TIA Submits Comments to FCC Regarding Draft Guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

ARLINGTON, VA (September 12, 2013) – The Telecommunications Industry Association (TIA), the leading association representing the manufacturers and suppliers of high-tech communications networks, today filed comments with the Food and Drug Administration (FDA) in response to its issuance of draft guidance on the content of premarket submissions for the management of cybersecurity in medical devices.

In its comments to the FDA, TIA urged that the draft guidance incorporate cybersecurity standards in the medical device setting; that the FDA should not require a device manufacturer to attest to malware after the device is handled by a third-party; and that the FDA clarify that it will not typically review medical device software changes made solely to strengthen cybersecurity. Carefully crafted, TIA believes that this important guidance will provide medical device manufacturers and components thereof with increased certainty, leading to enhanced innovation and investment.

About TIA

The Telecommunications Industry Association (TIA) represents manufacturers and suppliers of global communications networks through standards development, policy and advocacy, business opportunities, market intelligence, and events and networking. TIA enhances the business environment for broadband, mobile wireless, information technology, networks, cable, satellite and unified communications. Members' products and services empower communications in every industry and market, including healthcare, education, security, public safety, transportation, government, the military, the environment, and entertainment. Visit tiaonline.org for more details.

TIA is accredited by the American National Standards Institute (ANSI), and is a proud sponsor of ANSI’s Standards Boost Business campaign. Visit www.standardsboostbusiness.org  for details.

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