There are plenty of typical mistakes that FDA investigators find when inspecting device firms, from failing to adequately document complaints and ensuring proper process validation, to developing ambiguous design inputs during design control activities. Yet what really grates investigators’ nerves is when they have to ask manufacturers several times for procedures and processes that are routinely asked for during an inspection. “Let’s get beyond the things that you know are going to be needed and have them readily available,” says Phil Pontikos, an agency investigator and FDA’s national device expert. In fact, firms that attempt to conceal information or stall an investigator leave themselves open to additional scrutiny by the agency. “If you want to play games, then quite frankly, we’re going to dig deep,” Pontikos says.
Device manufacturers that attempt to avoid sharing quality system information with FDA during a facility inspection can stretch the time of the audit and create unnecessary friction between the agency and firms, FDA investigators say.
“My pet peeve is when companies play games. I hate that they know what I’m asking for but I have to ask for it four different ways until I get...
The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.
States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
