Ind Medical Device

Investigational Drugs and Devices (IND/IDE) - Harvard …

https://catalyst.harvard.edu/regulatory/ind-ide/

As defined by the Food and Drug Administration (FDA), an IND, or investigational new drug application, is a request for authorization from the FDA to administer an investigational drug or biological product to humans. An IDE, or investigational device …

https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/investigational-new-drug-applications-inds-cber-regulated-products

An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to …

IND Applications for Clinical Investigations: Regulatory …

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-regulatory-and-administrative-components

IND Applications for Clinical Investigations: Regulatory and Administrative Components IND Applications for Clinical Investigations: Regulatory and Administrative …

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 …

Investigational New Drug (IND) Application | FDA

https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application

Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

What is a medical device? The FDA defines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or …