Compassionate Use Fda Medical Device

Expanded Access for Medical Devices | FDA

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

Expanded Access | FDA - U.S. Food and Drug …

https://www.fda.gov/news-events/public-health-focus/expanded-access

For general questions, or if you are unsure of who to contact, contact the Patient Affairs Staff at 301-796-8460 or [email protected]. 2. After 4:30 p.m. ET …

Expanded Access | Information for Industry | FDA

https://www.fda.gov/news-events/expanded-access/expanded-access-information-industry

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening ... Drug, Biologic, and …

Expanded Access | Information for Patients | FDA

https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or life-threatening disease or condition to try an …

Expanded Access | Information for Physicians | FDA

https://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians

On average, FDA determines that the vast majority of all expanded access requests may proceed. Sometimes called “compassionate use”, expanded access is a …

Expanded Access (Compassionate Use) Submission …

https://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data

99.2%. 1 Expanded Access requests outside of an IDE are limited to single patient compassionate use requests. 2 Evaluable requests are requests in which a …

Emergency Use and Compassionate Use of …

https://www.fda.gov/files/medical%20devices/published/Presentation--Institutional-Review-Board--Compassionate-and-Emergency-Use-%28PDF-Version%29.pdf

2. Learning objectives. z. Understand when an emergency need to use an unapproved device may occur. z. Describe the role and responsibilities of the physician who wants to …

Compassionate Use, and HDE Pathways …

https://www.aaos.org/contentassets/a470b4bfc3b042b099b3312a1477f847/advocacy2_f1.pdf

compassionate use request (CUR), and humanitarian device exemp-tion (HDE)—that we as surgeons may use in treating our patients. Custom devices Physicians have been …

Emergency Use and Compassionate Use of …

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

Use of an investigational drug, biological product, or medical device generally requires either an IND (for unapproved drugs and biologics) or an IDE (for …

Single Patient IND for Compassionate or Emergency Use

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/physician-request-single-patient-ind-compassionate-or-emergency-use

For general questions about expanded access for emergency use for investigational drugs, contact CDER’s Division of Drug Information (DDI) at phone: 301-796-3400 or 855-543 …