Use Of Unapproved Medical Device

Expanded Access for Medical Devices | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/expanded-access-medical-devices

Frequently Asked Questions About Medical Devices | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-about-medical-devices

This document supersedes Medical Devices, Frequently Asked Questions about IRB Review of Medical Devices, and Emergency Use of Unapproved Medical Devices (September …

Expanded Access to Unapproved Medical Devices

https://research.virginia.edu/irb-hsr/expanded-access-unapproved-medical-devices

NOTE: An emergency use DOES NOT require IRB Concurrence or FDA approval BEFORE use. Unapproved medical device: is a device that is utilized for a purpose, condition, or …

Expanded Access to Unapproved Devices - UCI Office of …

https://research.uci.edu/human-research-protections/clinical-research/devices-used-in-clinical-research/expanded-access-to-unapproved-medical-devices/

Key Definitions: Unapproved medical device is a device that is utilized for a purpose, condition, or use for which the device requires, but does not have, an approved …

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/

FDA to clarify role of off-label uses in medical device approvals. September 23, 2020 By Nancy Crotti. The FDA has released proposed regulations to make clear that …

27.2 Emergency Use of Unapproved Medical Devices

https://eprostarchive.med.miami.edu/Eprost/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5B9C72738B1762C347B3350706BDD58021%5D%5D

An unapproved medical device is defined as a device that is used for a purpose or condition for which the device requires, but does not have, an approved …

Emergency Use and Compassionate Use of …

https://irb.ucsf.edu/emergency-use-and-compassionate-use-experimental-drugs-and-devices

The following criteria must be met to comply with federal regulations and University policy on emergency use of unapproved drugs, biologics and devices. The …

Displaying Investigational and Unapproved Medical …

https://www.mddionline.com/news/displaying-investigational-and-unapproved-medical-devices-according-fda-policy

Manufacturers who follow FDA's policies when showing investigational or unapproved devices­whether at a trade show or on a Web site­can avoid arousing the agency's …

When FDA Leaves Doctors to Their Own Devices – OMIC

https://www.omic.com/when-fda-leaves-doctors-to-their-own-devices/

A related, riskier issue—the use of unapproved devices—was recently brought to OMIC’s attention by an insured who inquired about the soft tissue filler, Restylane, an injectable, …

Unapproved Devices | Medical Equipment Fraud

https://www.whistleblowerfirm.com/medical-equipment-fraud/unapproved-medical-devices-and-uses/

Unapproved Devices Medical Equipment Fraud Attorneys. Nolan Auerbach & White is an experienced Medical Equipment Fraud Law Firm helping courageous whistleblowers. …