Jeff Craven

COLUMBUS, OH – The US Food and Drug Administration (FDA) saw more new recall events for class I medical devices in 2025 than it has in recent years, a trend that continues to trouble agency officials.

COLUMBUS, OH – It isn't always clear when to choose to verify or validate manufacturing processes. But experts from the US Food and Drug Administration (FDA) recently offered some tips for helping to make sense of the decision.

COLUMBUS, OH – Changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are in the pipeline, but a speaker at a recent meeting told attendees not to change their priorities based on proposed legislation.

Key changes with the QMSR include a greater focus on risk management, a culture of quality, and lifecycle integration. One of the biggest changes, officials said, is that risk is at the center of quality processes

COLUMBUS, OH – The US Food and Drug Administration (FDA) and representatives from industry have reached an agreement in principle on negotiations for reauthorization of the Medical Device User Fee Amendments (MDUFA VI) program, an FDA official told attendees at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

COLUMBUS, OH – The US Food and Drug Administration’s (FDA) top medical device official touted her center’s recent accomplishments and provided an update on several ongoing initiatives at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

COLUMBUS, OH – The difference between an anomaly and a defect in product software can be confusing, but it is important to identify which is which to properly handle problems that crop up in product software, two panelists recently told attendees, at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good manufacturing practice (CGMP) requirements, and one firm that has failed to submit an approved application for premarket approval (PMA).

The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on chemistry, manufacturing, and controls (CMC) flexibilities for cell and gene therapy (CGT) products developed for biologics license applications (BLAs).

More flexibility in early-phase development for cell therapies is needed, a panel of US Food and Drug Administration (FDA) representatives and industry members said at a public meeting hosted by Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy.