Investigational Medical Device Guidance

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IDE Guidance | FDA - U.S. Food and Drug Administration

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

Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies - Guidance for Industry and Food and Drug ...

IDE Responsibilities | FDA

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

Promotion of Investigational Devices (§812.7) Under §812.7, a sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator cannot: ...

Investigational Device Exemption (IDE) | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to …

IDEs for Early Feasibility Medical Device Clinical Studies …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-device-exemptions-ides-early-feasibility-medical-device-clinical-studies-including

This document is intended to provide guidance to FDA staff, clinicians, medical device innovators, and industry on the development and review of Investigational Device …

Clinical Trials and IDE Guidance Documents | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/clinical-trials-and-ide-guidance-documents

FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - Guidance …

IDE Approval Process | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process

In order to conduct a significant risk device study, a sponsor must: submit a complete IDE application ( §812.20) to FDA for review and obtain FDA approval of the …

Investigational Medical Devices - Hopkins Medicine

https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/devices.html

An IDE is issued by the FDA to allow the use investigational devices in human subjects. The IDE permits use of the device in a clinical investigation to evaluate the safety and/or …

Investigational IVDs Used in Clinical Investigations of …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-ivds-used-clinical-investigations-therapeutic-products

Therefore, use of an investigational IVD in a therapeutic product trial 29 may pose significant risk to subjects. FDA is concerned that sponsors (including sponsor-30 …

Investigational Medical Devices | Research - University …

https://research.virginia.edu/irb-hsr/investigational-medical-devices

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 application for premarket …

Devices Guidances | FDA - U.S. Food and Drug …

https://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances

Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff. CDRH/CBER/OCP/CDER, July 2020. …

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