Stay updated with breaking news from Quality System Considerations. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
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The U.S. Food and Drug Administration (FDA) recently released its draft guidance with a proposal to add a Section VII.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This draft guidance identifies the cybersecurity information FDA considers to generally be necessary for cyber devices under section 524B of the FD&C Act.