The Risk of Using a Device Off-Label Versus Contraindicated
While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.
Tag Archives: device labeling
Safe harbor for voluntary corrections of drug or device “misinformation” clarified in FDA guidance
Law firm, Hogan Lovells, analyzes the changes to the updated enforcement policy and provide key takeaways for entities responsible for communication regarding approved/cleared medical products.
Abiomed Updates IFU for Impella Blood Pumps Due to Perforation Risks
Use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death. To date, there have been 129 reported serious injuries, including 49 reports of death.
Why Human Factors Engineering Matters in Medical Device Packaging
By applying HFE principles early on, packaging design can evolve beyond usability evaluations in product development cycles to ultimately ensure a better user experience and safe execution.
Life Sciences Labeling for Patient Safety
Life sciences companies have a lot of factors to consider when it comes to labeling. Understanding the global labeling regulations for patient safety and how enterprise labeling solutions can help companies achieve compliance while assuring speed to market, and labeling system validation and auditability, can save resources and reduce costly errors.
Device Labeling: Best Practices
Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use.
FDA Helps Manufacturers Address Security and Risk of Interoperable Medical Devices
The agency issued a draft guidance that gives manufacturers information about design considerations and pre-market submissions.