Investigational Medical Devices

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. Clinical studies are most often...

Investigational Medical Devices - Hopkins Medicine

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

Medical devices include, among other things, surgical laser, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Medical devices …

IDE Responsibilities | FDA

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

Promote or test market an investigational device, until after FDA has approved the device for commercial distribution. Commercialize an investigational …

FAQs about Investigational Device Exemption | FDA

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

IDE Approval Process | FDA

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

Significant risk devices may include implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, …

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

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

Clinical Trials and IDE Guidance Documents FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services …

What is an investigational device exemption (IDE)?

https://www.news-medical.net/whitepaper/20230119/An-Investigational-Device-Exemption-(IDE)-what-is-it.aspx

An Investigational Device Exemption (IDE) is an application that must be submitted to receive the Food and Drug Administration’s (FDA) approval to use a novel …

GCP for Clinical Investigations of Devices | CITI Program

https://about.citiprogram.org/course/gcp-for-clinical-investigations-of-devices/

Describes the commitments and obligations assumed by investigators when conducting clinical investigations of devices, including investigator agreement, financial disclosures, …

eCFR :: 21 CFR Part 812 -- Investigational Device …

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812

( g) Investigational device means a device, including a transitional device, that is the object of an investigation. ( h) Investigation means a clinical investigation or research …

Investigational Medical Device | Neopemf

https://www.neopemf.com/investigational-medical-device/

Investigational Medical Device What is an investigational medical device? An investigational medical device is one that is the subject of a clinical study designed to …