Press Releases

AdvaMed Statement on HHS OIG Report on FDA Review of Medical Device Cybersecurity


Mark E. Brager
[email protected]
(202) 434-7244

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from Janet Trunzo, senior executive vice president, technology and regulatory affairs, on the HHS Office of Inspector General (OIG) report on FDA’s review process for medical device cybersecurity:

“AdvaMed supports the recommendations proposed in the HHS OIG’s report on FDA review of medical device cybersecurity. These process improvements by the FDA are consistent with AdvaMed’s Cybersecurity Principles and will reinforce activities already being done by medtech companies and the agency to help improve cybersecurity oversight by adding more transparency and predictability to the premarket review process. But these actions alone are not enough. Cybersecurity is a shared responsibility among all health care stakeholders. Providers have to do their part. Medtech companies are doing our part, and we look forward to continuing to partner with FDA.”