Quality System Considerations News Today

The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions.

Also: CloudWave and FDA extend their threat intelligence partnership to offer an open-source vendor assessment framework.

The U.S. Food and Drug Administration (FDA) recently released its draft guidance with a proposal to add a Section VII. to the Premarket Cybersecurity Guidance to support obligations...

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and...

This draft guidance identifies the cybersecurity information FDA considers to generally be necessary for cyber devices under section 524B of the FD&C Act.

The number of medical devices with wireless and network-connected capabilities continues to grow. At the same time, by some reports the number of ransomware attacks...

/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, the FDA...

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead...

Acknowledging the urgency of addressing new cyber threats on medical and healthcare devices, the US Food and Drug Administration (FDA) issued a guidance document

The Federal Communications Commission (FCC) has proposed a new voluntary cybersecurity labeling program intended to provide consumers easily…