The Impact of Human Factors Engineering Studies on 510(k) Success

510(k) Submissions Can Be RejectedWhy do approximately 30% of medical device 510(k) submissions fail* initial review? After spending extensive time and resources on a 510(k) submission, the worst n...

Patient Safety Issues with 503B Labeling and Packaging: Making the Case for Outsourcers to Follow FDA Guidance

While 503B outsourcing facilities must meet current good manufacturing practice requirements, they are not subjected to the same labeling and packaging safety standards and review process as recomm...

How Misleading Packaging Can Result in Wrong-Route Errors

The Institute for Safe Medication Practices (ISMP) received a safety concern from clinicians through its national error reporting program regarding the packaging of an enteral/oral probiotic. ISMP,...

Similar IV Bag Labels Can Lead to Error

Earlier this year, Med Safety Board’s parent organization and ECRI-affiliate, the Institute for Safe Medication Practices (ISMP), published an article entitled, Latent and active failures perfectly...

FDA finalizes guidance on safety considerations for container and carton labeling

On May 18, the US Food and Drug Administration (FDA) posted the finalized guidance for industry Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. ...