Fda Compassionate Use Medical Devices

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

Sometimes called “compassionate use”, ... For emergency requests for all medical products (drugs, biologics, and medical devices) contact FDA's Emergency …

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

Drug, Biologic, and Medical Device expanded access (“compassionate use”) program data Learning Resources Expanded Access: Recourse for Patients Out of …

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

4. Compassionate use of an unapproved device. unapproved device . z. Describe what is meant by compassionate use. z. The physician responsibilities with compassionate use

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Public Health Emergency Updates. Stay up to date as we continue to keep up our ongoing mission of protecting public health and spurring medical device innovation. "Our center …

Emergency Use and Compassionate Use of …

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

Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product.A patient may be able to …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803

TITLE 21--FOOD AND DRUGS. CHAPTER I--FOOD AND DRUG ADMINISTRATION. DEPARTMENT OF HEALTH AND HUMAN SERVICES. …

Custom Device Exemption - Food and Drug …

https://www.fda.gov/media/89897/download

to industry and FDA staff about implementation of the custom device exemption contained in Section 520(b) of the Food, Drug and Cosmetic Act (FD&C Act). …