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FDA Issues Draft Guidance on Cybersecurity Concerns & Revised IDE Clinical Investigations

Friday, June 14, 2013  
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The Food and Drug Administration (FDA) announced the issuance of two sets of draft guidance this week. While there have been no reports of patients being hurt by security failures, the first set, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," is intended to tighten cyber security concerns for medical device premarket submissions.

"Medical device innovators remain vigilant in maintaining the highest safety and security measures, and will work with FDA, hospitals and other stakeholders closely to address any concerns," said Mark Leahey, President and CEO of MDMA.  "It is crucial that as innovators seek to develop technologies to improve patient care and alleviate suffering, we clearly identify what the potential problems are, and ensure that any new regulations are reasonable."

The second guidance set, "FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations," revises initial guidance issued on November 10, 2011 due to provisions in FDASIA and is intended to provide clarification on the implications of FDA IDE decisions and explanations. 

The cybersecurity draft guidance can be viewed by clicking here. The IDE draft guidance can be viewed by clicking here. FDA is asking that comments on both sets of guidance be submitted by September 12, 2013.