Issues Associated With Off Label Use Of Medical Devices

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Issues associated with off label use of medical devices

https://pubmed.ncbi.nlm.nih.gov/18002765/

One example here is the currently controversial topic of the reuse of devices labeled single use only, although off label use is a far more widespread issue than reuse. The justification for off label use can range from reasoned and studied applications beyond those for …

Off-Label Use of Marketed Drug or Device

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and-investigational-use-marketed-drugs-biologics-and-medical-devices

If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm …

Issues Associated with Off Label Use of Medical Devices …

https://ieeexplore.ieee.org/document/4353099

Issues Associated with Off Label Use of Medical Devices. Abstract: Off label use as applied to medical devices is the application of the device for a purpose …

FDA to clarify role of off-label uses in medical device …

https://www.medicaldesignandoutsourcing.com/fda-to-clarify-role-of-off-label-uses-in-medical-device-approvals/

Off-label use may be harmful, as evidenced by a 2019 FDA warning that off-label use of Stryker ‘s (NYSE: SYK) Wingspan stent system, designed to open …

[Ethical and legal problems arising from off-label use of …

https://pubmed.ncbi.nlm.nih.gov/29853702/

Since the off-label use of medical devices cannot rely on scientifically proven, evidence-based information, evaluation of the risks creates critically important ethical problems …

Understanding Unapproved Use of Approved Drugs "Off …

https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label

Unapproved use of an approved drug is often called “off-label” use. This term can mean that the drug is: Used for a disease or medical condition that it is not approved to treat, …

Off-label use and medical devices: Here's …

https://www.medicaldesignandoutsourcing.com/off-label-use-medical-devices-heres-need-know/

Promoting off-label use of a medical device – a use not included on a device’s indication with FDA – has become a dangerous practice for medtech insiders, with some facing potential …

Issues Associated with Off Label Use of Medical Devices

https://www.researchgate.net/publication/5843757_Issues_Associated_with_Off_Label_Use_of_Medical_Devices

The justification for off label use can range from reasoned and studied applications beyond those for which the manufacturer has sought clearance or approval, …

Ethical and Legal Considerations of Off …

https://decisionsindentistry.com/article/ethical-and-legal-considerations-of-off-label-drug-use/

As off-label drug use continues to increase in dentistry, legal claims can potentially arise, making it vital for dental professionals to understand the legal implications associated with …

What to know about off-label drug use - Medical News …

https://www.medicalnewstoday.com/articles/off-label-drug-use

A person is unable to take the FDA-approved drug due to side effects or possible interactions with other drugs they are taking. The doctor has seen evidence that …

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