ISO 80369-7: Changing the Standard for Luer Connectors

ISO 80369 Part 7, the long-awaited replacement to ISO 594, introduced a number of changes to the standard governing dimensions and performance requirements of Luer connectors. Its publication in October 2016 capped a monumental change in the fundamental thinking surrounding devices that transfer liquids and gases in healthcare settings. Despite the Technical Committee’s desire to disrupt as little as possible surrounding the current practices with Luer connectors, ISO 80369-7 still makes many significant changes.

MasterControl Study: FDA, CPSC Recalls Up 115% Since 2018

MasterControl , a provider of quality and manufacturing software solutions for the life sciences industry, has released a new study analyzing five years of product recall data from the Food and Drug Administration (FDA) and Consumer Product Safety Commission (CPSC) showing that recalls have increased more than 115 percent since 2018.

FDA Clarifies Recommendations on Cardinal Health Monoject Recall

The new letter by FDA aimed to expand the recall notice to PCA pumps, which the original recall did not mention. It’s that gap in information that concerned FDA.

FDA Finalize Human Factors Guidance in Combination Medical Devices

Replacing a draft guidance issued in February 2016, FDA recently finalized its guidance on the use of human factors engineering (HFE) in the development of combination medical devices with a drug or biological product.

FDA Hits Integra with Warning Letter

Editor’s note: This story has been updated to include a statement from Integra LifeSciences about the FDA warning letter.

ISO Chemical Characterization for Medical Devices

By comprehensively evaluating the allowed limit of extractable chemical levels in medical devices, manufacturers can ensure that their device is safe for its intended use.

FDA Focuses on Modernizing Clinical Trials

The watchdog agency’s draft guidance will also focus on digital health technologies.

FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers

The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive review of test protocols and results for each submission, a process that can be burdensome for both manufacturers and regulatory bodies.

Timeline Mystery for Updated EtO Rules

Thirty-six months (give or take a few) filled with controversy, legal battles, protests, anxiety, anger, and bewilderment—with likely more to come.

FDA updates guidance on identifying and responding to deficiencies