Have you provided cybersecurity labeling for your medical device?

Submitting to FDA? - Adequate cybersecurity labeling is important to comply with the requirement specified in section 524B(b)(2) of the FD&C Act to provide a reasonable assurance that the device and related systems are cybersecure. As such, please ensure cybersecurity labeling is provided as per the recommendation in Section VI.A of the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"

Please feel free to contact our team if you have any questions regarding the labeling and cybersecurity requirements for your pre-market submission.