Ide Approval Medical Devices

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, mitigating or treating disease...

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 …

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

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

FAQs about Investigational Device Exemption | FDA

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

If my device has been approved and marketed in a foreign country and I am conducting clinical trials in the U.S., should I report an adverse event from the U.S. trial under the …

Expanded Access for Medical Devices | FDA

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

Approval of treatment IDEs Treatment use under a treatment IDE may begin 30 days after the FDA receives the treatment IDE submission. The FDA may notify the …

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 …

IDE Responsibilities | FDA - U.S. Food and Drug …

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: …

Import and Export of Investigational Devices | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/import-and-export-investigational-devices

Recordkeeping Requirements for All Exported Investigational Devices Import A person who imports or offers to import an investigational device shall be considered an agent for the …

FDA grants IDE approval for Concept Medical’s Coated Balloon

https://www.medicaldevice-network.com/news/fda-concept-medical-coated-balloon/

The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to Concept Medical’s Magic Touch Sirolimus Coated …

Concept Medical’s MagicTouch PTA SCB Receives IDE Approval …

https://evtoday.com/news/concept-medicals-magic-touch-pta-scb-receives-ide-approval-to-study-treatment-of-btk-arterial-disease

February 13, 2023—Concept Medical Inc. announced that its MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus-coated balloon (SCB) has …