Hello. I’m Joseph Tartal, Deputy Director of the Division of Industry and Consumer Education, in the Center for Devices and Radiological Health, at the U.S. Food and Drug Administration. Welcome to ...

The United States Food and Drug Administration (FDA) has released updated cybersecurity guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket ...

Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...

The US Food and Drug Administration’s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section ...

On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System ...

With technological advancements in the medical device industry come heightened regulatory expectations, and rightly so. Of late, regulatory expectations for medical devices are shifting faster than ...

The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical device production. FDA said the draft ...

The FDA's new Quality Management System Regulation doesn't just align American standards with global practice—it fundamentally redefines what regulators mean by 'quality.' Medical device companies ...

The FDA has notified the medical device manufacturing sector that ISO-13485(2016) will be recognized as a Quality Management System Consensus Standard. In February 2026, the FDA will move away from ...