FDA's Risk-Based Approach To Facility Inspections Undergoing Refinements

FDA IS REVIEWING ITS RISK-BASED INSPECTION APPROACH to make sure it is learning all it can about problematic manufacturers and devices. The agency weighs product and manufacturer risk when deciding which firms to inspect, but “we're working to improve our model,” says Larry Spears, deputy director of regulatory affairs in CDRH's Office of Compliance. “We want to get input from other parts of the agency, particularly the Office of Regulatory Affairs, to help us make sure that we're truly identifying all risk.” Speaking from the trenches, Baltimore District Office device investigator Lori Lawless tells manufacturers what to expect during an FDA inspection. Because investigators use FDA's publicly available Quality System Inspection Technique, “there should really be no reason why an FDA-483 form needs to be issued,” she says.

More from Archive

More from Medtech Insight

US Could Lose Its First Approver Advantage After FDA Layoffs

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

Staff Cuts At CDRH Focus On Administrative Workers, Spare Reviewers

 

About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.

Global Medtech Guidance Tracker: March 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.