Humanitarian use devices - Study guides, Class notes & Summaries

Humanitarian Use Devices (HUDs) Test ...

Humanitarian Use Devices (HUDs) Exam 100% Correct Although not required by regulation, which of the following actions does FDA guidance recommend for clinical use of a HUD outside of its approved indication(s)? Restrict use outside of approved indication(s) for situations that meet emergency use criteria. Obtain informed consent from the patient and ensure that reasonable patient protection measures are followed. Request that the HDE holder submit an HDE supplement to obtain FDA approv...

Humanitarian Use Devices (HUDs)

Humanitarian Use Devices

TEA process - 21 CFR 330-14 add established ingredient to existing OTC monograph Request for Designation (RFD) - ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt - no effectiveness data required misbranded device - not cleared through 510k process (but needs one) adultered device - does not have PMA but needs one design input for device - requirements that must be met IDE (Investigational Device Exemption) - report within 5 working days: emergencies, use ...

Humanitarian Use Devices

GCP Of Devices Questions And Answers 2024. 510(k) Clearance - CORRECT ANSWER A 510(k) clearance or premarket notification [(510(k)] submission is a route the FDA uses to approve a medical device. If the FDA agrees the new device is substantially equivalent to a legally marketed device for which a premarket approval (PMA) is not required, the manufacturer may market it immediately. Humanitarian Device Exemption (HDE) Holder - CORRECT ANSWER The HDE Holder is the entity that obtains the ap...

GCP of Devices Questions and Answers | Latest Version | 2024/2025 | Already Passed What is a 510(k) clearance? A 510(k) clearance, also known as premarket notification, is an FDA approval process for medical devices. If the FDA determines that a new device is substantially equivalent to an existing legally marketed device that does not require premarket approval (PMA), the manufacturer can market the new device immediately. Who is the Humanitarian Device Exemption (HDE) holder? ...

GCP of Devices Questions and Answers 100% correct 510(k) Clearance A 510(k) clearance or premarket notification [(510(k)] submission is a route the FDA uses to approve a medical device. If the FDA agrees the new device is substantially equivalent to a legally marketed device for which a premarket approval (PMA) is not required, the manufacturer may market it immediately. Humanitarian Device Exemption (HDE) Holder The HDE Holder is the entity that obtains the approval of a HDE from the ...

Humanitarian Use Devices (HUDs) question and answer 100% correct Although not required by regulation, which of the following actions does FDA guidance recommend for clinical use of a HUD outside of its approved indication(s)? Restrict use outside of approved indication(s) for situations that meet emergency use criteria. Obtain informed consent from the patient and ensure that reasonable patient protection measures are followed. Request that the HDE holder submit an HDE supplement to obtain...