The FDA’s Role in Medical Device Cybersecurity

Cybersecurity issues arise when medical devices are capable of connecting to the Internet or other medical devices. Since the FDA is concerned with regulating the safety and effectiveness of medical devices, manufacturers must ensure that the computer systems of medical devices are protected against security breaches.

The link below provides the FDA Fact Sheet entitled, “The FDA’s Role in Medical Device Cybersecurity.” The document dispels some common myths about medical device cybersecurity. Notably, the document makes two important points about cybersecurity as it pertains to software:

  1. The FDA is not responsible for the validation of software changes made to address cybersecurity vulnerabilities – it is the medical device manufacturer that is responsible for validating all software design changes.
  2. The manufacturer of off-the-shelf (OTS) software used in medical devices is not the one responsible for validating its secure use in medical devices – it is the responsibility of the medical device manufacturer that chooses to use OTS software who is responsible for the security of the software for medical devices.

Cybersecurity Fact Sheet 2019

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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